KNUMBER|APPLICANT|CONTACT|STREET1|STREET2|CITY|STATE|COUNTRY_CODE|ZIP|POSTAL_CODE|DATERECEIVED|DECISIONDATE|DECISION|REVIEWADVISECOMM|PRODUCTCODE|STATEORSUMM|CLASSADVISECOMM|SSPINDICATOR|TYPE|THIRDPARTY|EXPEDITEDREVIEW|DEVICENAME DEN070001|CENTERS FOR DISEASE CONTROL AND PREVENTION|HYE-JOO KIM|1600 CLIFTON RD., N.E.||ATLANTA|GA|US|30333|30333|01/16/2007|09/21/2018|DENG|MI|PBK||MI||Post-NSE|N||NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET DEN170080|Adaptive Biotechnologies Corporation|B. Melina Cimler|1551 Eastlake Ave E, Ste 200||Seattle|WA|US|98102|98102|09/29/2017|09/28/2018|DENG|PA|QDC||||Direct|N||Adaptive Biotechnologies clonoSEQ Assay K170702|mediCAD Hectec Gmbh|Claas-Fabian Luers|Opalstrasse 54||Altdorf||DE|84032|84032|03/08/2017|09/07/2018|SESE|RA|LLZ|Statement|RA||Traditional|N||mediCAD 4.0 K171532|TruAbutment Inc.|Brandon Kim|300 South Harbor Blvd #520||Anaheim|CA|US|92805|92805|05/25/2017|09/11/2018|SESE|DE|NHA|Summary|DE||Traditional|N||TruBase S K171696|Praxair Distribution, Inc|Michael E. Skrjanc|10 Riverview Drive||Danbury|CT|US|06810|06810|06/07/2017|10/02/2018|SESE|AN|MRN|Summary|AN||Traditional|N||NOxBOXi Nitric Oxide Delivery System K171904|Microware Precision Co., Ltd.|Harrison Du|No. 12, Keyuan 2nd Rd.,|Situn District|Taichung||TW|407630|407630|06/26/2017|09/18/2018|SESE|OR|HRS|Summary|OR||Traditional|N||Tandry Locking Plate System K171947|AKTORmed GmbH|Andreas Mohr|Borsigstrabe 13||Barbing||DE|93092|93092|06/29/2017|09/21/2018|SESE|SU|NAY|Summary|GU||Traditional|N||SOLOASSIST II K172418|Novarad Corporation|Doug Merrill|752 East 1180 South #200||American Fork|UT|US|84003|84003|08/10/2017|09/21/2018|SESE|RA|LLZ|Summary|RA||Traditional|N||OpenSight K172450|WAT Medical Technology (Ningbo) Co., Ltd|Rodney Zhang|Room703-711, No.2 North Taoyuan Road||Ningbo||CN|315600|315600|08/14/2017|09/13/2018|SESE|NE|PCC|Summary|NE||Traditional|N||TENS device-HeadaTerm, eEspress K172826|Jiangsu Trauhui Medical Instrument Co.,Ltd.|Zhou Yu|No.2 Longqing Road, Wujin Hi-Tech Industrial Zone||Changzhou||CN|213118|213118|09/18/2017|10/10/2018|SESE|OR|NKB|Summary|OR||Traditional|N||Cellent Spinal Systems K172834|Shenzhen OSTO Technology Co., Ltd.|Li Yang|No.43 Longfeng Road, Xinsheng Community|Longgang Street Longgang District|Shenzhen||CN|||09/19/2017|09/06/2018|SESE|NE|NUH|Summary|NE||Traditional|N||Dual output digital therapy massager K172957|Kawasumi Laboratories, Inc.|Takayuki Nakajima|Shinagawa Intercity Tower B, 9th Floor|2-15-2, Konan, Minato-Ku|Tokyo||JP|108-6109|108-6109|09/26/2017|09/28/2018|SESE|HO|KSB|Summary|HE||Traditional|N||Kawasumi Laboratories Blood Drawing Kit (BDK) System K173076|FMI Medical Systems Inc.|Scott LeMaster|29001 Solon Road, UnitA||Solon|OH|US|44139|44139|09/29/2017|10/04/2018|SESE|RA|JAK|Summary|RA||Traditional|N||CURA 16; ScintCare CT16 K173127|Skyla Corporation H.S.P.B.|Cindy Lu|1f. No. 8, Dusing Rd., Hsinchu Science Park||Hsinchu||TW|30078|30078|09/29/2017|09/25/2018|SESE|CH|LCP|Summary|HE||Traditional|N||skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) K173141|CSM Implant|Sung Am Cho|B205 Techno B/D, 47|Gyeongdae-ro, 17gil, Buk-gu|Daegu||KR|41566|41566|09/29/2017|09/19/2018|SESE|DE|DZE|Summary|DE||Traditional|N||CSM Submerged3-L Implant System K173194|Orantech Inc.|Hsin Xiong|Zone#A,4F,1st Bld,7th Industrial Zone|Yulv Community, GongMing|Guangming New District, Shenzhen||CN|518106|518106|10/02/2017|10/10/2018|SESE|HO|FLL|Summary|HO||Traditional|N||Temperature Probe K173424|Synergy Biomedical|Mark Borden|100 Springhouse Dr.|Suite 108|Collegeville|PA|US|19426|19426|11/01/2017|09/12/2018|SESE|OR|MQV|Summary|OR||Traditional|N||BioSphere Flex K173568|Wallac Oy, Subsidiary of PerkinElmer, Inc.|Brian Carney|940 Winter Street||Waltham|MA|US|02451|02451|11/20/2017|09/04/2018|SESE|CH|NQL|Summary|CH||Traditional|N||NeoBase 2 Non-derivatized MSMS Kit K173642|Soadco, S.L.|Maria Mitjaneta|Avgda. Fiter I Rossell, 4 Bis- Local 2||Escaldes-Engordany||AD|AD700|AD700|11/24/2017|10/02/2018|SESE|HO|KCT|Summary|HO||Abbreviated|N||KLOCKNER SURGICAL BOX K173665|Amsino International, Inc.|Cathy Hong|708 Corporate Center Drive||Pomona|CA|US|91768|91768|11/29/2017|09/05/2018|SESE|HO|FPA|Summary|HO||Traditional|N||AMSafe Sure-Lok Needle-Free Connector K173676|HIRONIC Co., Ltd.|Sangwon Hwang|19F, 767, Sinsu-ro, Suji-gu||Gyeonggi-do||KR|16827|16827|11/30/2017|09/14/2018|SESE|SU|GEX|Summary|SU||Traditional|N||A-FIT K173716|Quest Medical, Inc.|Jan Hodges|One Allentown Parkway||Allen|TX|US|75002-4211|75002-4211|12/05/2017|10/01/2018|SESE|CV|DTR|Summary|CV||Traditional|N||MPS2 Myocardial Protection System Console K173765|Mortara Instrument, Inc.|Manisha Gokuli|7865 North 86th Street||Milwaukee|WI|US|53224|53224|12/11/2017|09/04/2018|SESE|CV|MHX|Summary|CV||Traditional|N||Surveyor Patient Monitor K173813|Shen Zhen CosBeauty Co., Ltd|Nicole Hu|UnitA-3F, Qiao De Industrial Park, Tian Liao,|GuangMing District|Shenzhen||CN|||12/15/2017|09/07/2018|SESE|SU|OHT|Summary|SU||Traditional|N||IPL Hair Removal Device Joy Version K173822|Conmed Corporation|Rachelle D Fitzgerald|525 French Road||Utica|NY|US|13502|13502|12/18/2017|09/11/2018|SESE|OB|GCJ|Summary|GU||Traditional|N||Anchor Tissue Retrieval System by CONMED K173827|LightScalpel LLC|David Walters|11818 North Creek Parkway N|Suite 100|Bothell|WA|US|98011|98011|12/18/2017|09/14/2018|SESE|SU|GEX|Summary|SU||Traditional|N||LightScalpel K173830|GE Medical Systems Information Technologies, Inc.|Marcella Entwisle|9900 West Innovation Drive||Wauwatosa|WI|US|53226|53226|12/18/2017|09/18/2018|SESE|CV|DPS|Summary|CV||Traditional|N||MAC VU360 Resting ECG Analysis System K173833|SENTINEL CH. SpA|Patricia Dupe|Via Robert Koch 2||Milano||IT|20152|20152|12/18/2017|09/27/2018|SESE|CH|NQD|Summary|IM||Traditional|N||CRP Vario K173871|Suzhou Hengrui Callisyn Biomedical Co., Ltd.|Xiao Chen|Buliding 9, No. 8 Jinfeng Road, New District||Suzhou||CN|215163|215163|12/20/2017|09/17/2018|SESE|OB|NAJ|Summary|CV||Traditional|N||CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres K173872|Qompium nv|Jo Van der Auwera|Kempische Steenweg 311/27||Hasselt||BE|3500|3500|12/20/2017|09/28/2018|SESE|CV|DXH|Summary|CV||Traditional|N||FibriCheck K173883|Life Spine Inc.|Randy Lewis|13951 S Quality Drive||Huntley|IL|US|60142|60142|12/21/2017|09/07/2018|SESE|OR|KTT|Summary|OR||Traditional|N||External Fixation System K173893|coLigne, AG|Robert Lange|Utoquai 43||Zurich||CH|CH 8008|CH 8008|12/21/2017|09/06/2018|SESE|OR|PLR|Summary|OR||Traditional|N||Trabis K173898|MicroPort Orthopedics Inc. (MPO)|Usman Rashid|5677 Airline Road||Arlington|TN|US|38002|38002|12/22/2017|09/20/2018|SESE|OR|LZO|Summary|OR||Traditional|N||MicroPort Orthopedics Total Hip Systems MR Labeling K173910|Cable Fix Medical LLC|Carey Bryant|1050 Getwell Road S||Hernando|MS|US|38632|38632|12/22/2017|09/14/2018|SESE|OR|JDQ|Summary|OR||Traditional|N||Impress SFS System K173920|J. Mortia USA, Inc.|Keith A. Barritt|9 Mason||Irvine|CA|US|92618|92618|12/22/2017|10/11/2018|SESE|DE|EKX|Summary|DE||Traditional|N||LS OIL K173921|Sonoscape Medical Corp.|Toki Wu|4/f, 5/f, 8/f, 9/f & 10/f|Yizhe building, Yuquan road, Nanshan|Shenzhen||CN|518051|518051|12/26/2017|09/05/2018|SESE|GU|NWB|Summary|GU||Traditional|N||HD-500 Video Endoscope System K173926|LAP GmbH Laser Applikationen|Martin Pfabel|Zeppelinstrasse 23||Lueneburg||DE|21337|21337|12/26/2017|09/14/2018|SESE|RA|IYE|Summary|RA||Traditional|N||DORADOnova MR3T K173933|Xenco Medical, LLC|Michelle Willis|9930 Mesa Rim Road||San Diego|CA|US|92121|92121|12/26/2017|09/13/2018|SESE|OR|MQV|Summary|OR||Traditional|N||Sorrento Bioglass Bone Graft Substitute K173941|Philips Medizin Systeme Boeblingen GmbH|Christoph Krause|Hewlett-Packard-Str.-2||Boeblingen||DE|71034|71034|12/26/2017|09/10/2018|SESE|OB|HGM|Summary|OB||Traditional|N||IntelliSpace Perinatal Rev.K.00 K173945|Institut Straumann AG|Christopher Klaczyk|Peter Merian Weg 12||Basel||CH|CH-4002|CH-4002|12/26/2017|10/05/2018|SESE|DE|NHA|Summary|DE||Traditional|N||Straumann SC Variobase Abutments K173960|DePuy France S.A.S.|David Holzwarth|7 Allee Irene Joliot Curie Bp256||Saint Priest Cedex Rhone-Alpes||FR|69801|69801|12/28/2017|09/21/2018|SESE|OR|LZO|Summary|OR||Traditional|N||DePuy Corail AMT Hip Prosthesis K173976|Masimo Corporation|Karina Simpson|52 Discovery||Irvine|CA|US|92618|92618|12/29/2017|09/05/2018|SESE|AN|BZQ|Summary|AN||Abbreviated|N||Masimo Acoustic Respiration Sensors, infant and neonate K173982|Globus Medical Inc.|Lori Burns|2560 General Armistead Ave.||Audubon|PA|US|19403|19403|12/29/2017|09/19/2018|SESE|OR|MQP|Summary|OR||Traditional|N||FORTIFY Corpectomy Spacers DEN180026|Bose Corporation|James Yeagle|The Mountain||Framingham|MA|US|01701|01701|05/11/2018|10/05/2018|DENG|EN|QDD||EN||Direct|N||Bose Hearing Aid K180029|Cook Incorporated|Minjin Choi|750 Daniels Way||Bloomington|IN|US|47404|47404|01/03/2018|09/21/2018|SESE|GU|FAD|Summary|GU||Traditional|N||Malecot Nephrostomy Catheter/Stent Set K180041|Applied Biocode, Inc.|Robert Di Tullio|10020 Pioneer Blvd.|Suite 102|Santa Fe Springs|CA|US|90670|90670|01/05/2018|09/28/2018|SESE|MI|PCH|Summary|MI||Traditional|N||BioCode Gastrointestinal Pathogen Panel (GPP) DEN180042|Apple Inc|Donna-Bea Tillman|||Alexandria|VA|US|22314|22314|08/09/2018|09/11/2018|DENG|CV|QDB||CV||Direct|N||Irregular Rhythm Notification Feature DEN180044|Apple Inc|Donna-Bea Tillman|c/o Biologics Consulting Group|400 N Washington St., Suite 100|Alexandria|VA|US|22314|22314|08/14/2018|09/11/2018|DENG|CV|QDA||CV||Direct|N||ECG App K180053|Cook Incorporated|Minjin Choi|750 Daniels Way||Bloomington|IN|US|47404|47404|01/08/2018|09/13/2018|SESE|GU|FAD|Summary|GU||Traditional|N||Sof-Flex Ureteral Stent Set K180054|Cook Incorporated|Jessica Swafford|750 Daniels Way||Bloomington|IN|US|47402|47402|01/08/2018|10/05/2018|SESE|CV|DQO|Summary|CV||Traditional|N||Royal Flush Plus High-Flow Catheter K180068|Boston Scientific|Thomas Hirte|100 Boston Scientific Way||Marlborough|MA|US|01752|01752|01/09/2018|09/28/2018|SESE|GU|PLL|Summary|GU||Traditional|N||ORISE Gel K180099|The Binding Site Group Ltd|Kirsty Samuels|8 Calthorpe Road, Edgbaston|West Midlands|Birmingham||GB|B15 1QT|B15 1QT|01/16/2018|10/12/2018|SESE|CH|DCN|Summary|IM||Traditional|N||Optilite High Sensitivity C-Reactive Protein Kit K180144|Boston Scientific Corporation|Kayla Mackey|100 Boston Scientific Way||Marlborough|MA|US|01752|01752|01/18/2018|09/21/2018|SESE|GU|ESW|Summary|SU||Traditional|N||Agile Esophageal Stent System K180177|Shanghai Kindly Medical Instruments Co., Ltd.|Xu Jianhai|No. 925, Jinyuan yi Road||Shanghai||CN|201803|201803|01/22/2018|09/13/2018|SESE|CV|DQX|Summary|CV||Traditional|N||Guidewire K180178|Shanghai Kindly Medical Instruments Co., Ltd.|Xu Jianhai|No. 925, Jinyuan yi Road||Shanghai||CN|201803|201803|01/22/2018|09/10/2018|SESE|CV|DYB|Summary|CV||Traditional|N||Introducer Set K180182|Cook Incorporated|Samuel Engelman|750 Daniels Way||Bloomington|IN|US|47404|47404|01/23/2018|09/14/2018|SESE|GU|EYB|Summary|GU||Traditional|N||Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter K180209|Diazyme Laboratories Inc.|Abhijit Datta|12889 Gregg Court||Poway|CA|US|92130|92130|01/24/2018|10/04/2018|SESE|CH|NOZ|Summary|HE||Traditional|N||Diazyme 1,5-AG Assay K180215|Life Spine Inc.|Randy Lewis|13951 S Quality Drive||Huntley|IL|US|60142|60142|01/25/2018|09/13/2018|SESE|OR|OVD|Summary|OR||Traditional|N||DYNA-LINK ELITE Stand-Alone Anterior Lumbar System K180216|Cook Incorporated|Rebecca Odulio (Li-Chun-Liu)|750 Daniels Way P.O. Box 489||Bloomington|IN|US|47402|47402|01/25/2018|09/28/2018|SESE|GU|FAD|Summary|GU||Traditional|N||Seidmon Antegrade AQ Stent Set K180241|Ortho Caps GmbH|Wajeeh Khan|An der Bewer 8||Hamm 59069||DE|||01/29/2018|09/28/2018|SESE|DE|NXC|Summary|DE||Traditional|N||Orthocaps Twinaligner K180249|Matrix Surgical Holdings, LLC/Matrix Surgical USA|John O'Shaughnessy|4025 Welcome All Road|Suite 120|Atlanta|GA|US|30349|30349|01/29/2018|10/11/2018|SESE|DE|JEY|Summary|DE||Traditional|N||OmniPore DUROMAX Surgical Implants K180292|PENTAX Medical of America, Inc|James W. Monroe|3 Paragon Drive||Montvale|NJ|US|07645-1782|07645-1782|02/01/2018|10/12/2018|SESE|GU|FDS|Summary|GU||Traditional|N||PENTAX Video Upper G.I. Scope EG34-i10 K180338|Ward Photonics LLC|Terry Ward|1980 N Atlantic Avenue||Cocoa Beach|FL|US|32931|32931|02/07/2018|09/21/2018|SESE|SU|OLI|Summary|SU||Traditional|N||Cellulize K180340|Nova Biomedical Corporation|Adam Heroux|200 Prospect St.||Waltham|MA|US|02454|02454|02/07/2018|09/26/2018|SESE|CH|CGA|Summary|CH||Traditional|N||Stat Profile Prime Plus Analyzer System K180366|Monarch Medical Technologies, Inc.|Linda Beneze|2137 South Blvd|Suite 300|Charlotte|NC|US|28203|28203|02/12/2018|09/20/2018|SESE|HO|NDC|Summary|AN||Traditional|N||EndoTool SubQ K180369|Relievant Medsystems|Alex DiNello|385 Moffett Park Drive, Suite 105||Sunnyvale|CA|US|94089|94089|02/12/2018|09/14/2018|SESE|NE|GXI|Summary|NE||Traditional|N||Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) K180446|b-One Ortho Corp.|Allison Gecik|3 Wing Drive Suite #259||Cedar Knolls|NJ|US|07927|07927|02/20/2018|10/12/2018|SESE|OR|JWH|Summary|OR||Traditional|N||b-ONE Total Knee System K180465|Southern Implants (Pty) Ltd|Lauranda G. Breytenbach|1 Albert Road||Irene||ZA|0062|0062|02/21/2018|09/06/2018|SESE|DE|DZE|Summary|DE||Traditional|N||Provata Implant System K180467|Showa Best Glove, Inc|Jeffrey Richardson|579 Edison Street||Menlo|CA|US|30731-6335|30731-6335|02/21/2018|10/10/2018|SESE|HO|LZA|Summary|HO||Traditional|N||SBG Blue Nitrile Powder Free Medical Examination Glove K180468|Showa Best Glove, Inc.|Jeffrey Richardson|579 Edison Street||Menlo|CA|US|30731-6335|30731-6335|02/21/2018|10/10/2018|SESE|HO|LZA|Summary|HO||Traditional|N||SBG Black Nitrile Powder Free Medical Examination Glove K180489|Teva Medical Ltd., Migada Plant|Nadav Reuben|North Industrial Zone||Kiryat Shmona||IL|10258|10258|02/23/2018|09/21/2018|SESE|HO|ONB|Summary|HO||Traditional|N||TEVADAPTOR Closed Drug Reconstitution and Transfer System K180555|JK Holding GmbH|Juergen Gerstenmeier|Koehlershohner Strasse 60||Windhagen||DE|53578|53578|03/01/2018|10/11/2018|SESE|SU|LEJ|Summary|SU||Traditional|N||Ergoline Prestige 1600 Hybrid Performance K180620|Endophys Holdings, LLC|Phillip Purdy|1601 Elm Street, Suite 3500||Dallas|TX|US|75201|75201|03/09/2018|10/12/2018|SESE|CV|DYB|Summary|CV||Special|N||Endophys Pressure Sensing Sheath Kit K180680|Laclede, Inc.|Michael Pellico|2103 E. University Dr.||Rancho Dominguez|CA|US|90220|90220|03/15/2018|10/11/2018|SESE|DE|LFD|Summary|||Traditional|N||Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray K180714|K-jump Health Co., Ltd.|JM Lin|No. 56, Wu Kung 5th Rd. New Taipei Industrial Park||New Taipei City||TW|24890|24890|03/19/2018|09/24/2018|SESE|HO|FLL|Summary|HO||Abbreviated|N||Probe Covers for Thermometers K180728|Spinal Elements Inc|Julie Lamothe|3115 Melrose Dr., Suite 200||Carlsbad|CA|US|92010|92010|03/20/2018|09/06/2018|SESE|OR|OWI|Summary|OR||Traditional|N||Spinal Elements Cerclage System K180736|WishBone Medical, Inc.|Gary Barnett|1250 North Pointe Drive||Warsaw|IN|US|46992|46992|03/22/2018|10/04/2018|SESE|OR|HRS|Statement|OR||Traditional|N||WishBone Medical Plate and Screw System K180778|MT.DERM GmbH|Anderas Pachten|Gustav-Krone-Str.3||Berlin||DE|14167|14167|03/26/2018|09/07/2018|SESE|SU|QAI|Summary|SU||Traditional|N||Exceed Microneedling Device K180781|C. R. Bard, Inc.|Sharon Lambert|8195 Industrial Blvd.||Covington|GA|US|30014|30014|03/26/2018|09/19/2018|SESE|GU|EZL|Summary|GU||Traditional|N||Bard Vertus Foley Catheter K180803|Shofu Dental Corporation|Mauro Malzyner|1225 Stone Drive||San Marcos|CA|US|92078|92078|03/28/2018|09/26/2018|SESE|DE|KLE|Statement|DE||Traditional|N||BeautiBond Universal K180871|MicroBase Technology Corporation|Molly Hsieh|No. 756, Jiadong Road||Bade District, Taoyuan City||TW|33464|33464|04/03/2018|09/14/2018|SESE|AN|CAF|Summary|AN||Traditional|N||Portable Nebulizer K180872|Viol Co., Ltd.|Chai Kyoung Woo|C-808, 809 Bundang Technopark C, 744, Pangyo-ro Bundang-gu||Seongnam-si||KR|13510|13510|04/03/2018|10/11/2018|SESE|SU|GEI|Summary|SU||Traditional|N||SCARLET SRF K180875|Medtek Skincare, LLC|Gary Richardson|3 Depot Street||Hudson Falls|NY|US|12839|12839|04/03/2018|09/14/2018|SESE|SU|OHS|Summary|SU||Traditional|N||POLY REJUV K180893|Protege Biomedical|Mike Corcoran|10909 Valley View Rd.||Eden Prairie|MN|US|55344|55344|04/05/2018|09/19/2018|SESE|SU|FRO|Summary|||Traditional|N||IHM Technology Bandage K180894|Levita Magnetics International Corp.|Alberto Rodrigues-Navarro|1730 S. Amphlett Blvd, Suite 240||San Mateo|CA|US|94402|94402|04/05/2018|09/19/2018|SESE|SU|PNL|Summary|SU||Traditional|N||Magnetic Surgical System K180916|TeraRecon Inc.,|Megha Jain|4000 East 3rd Avenue, Suite 200||Foster City|CA|US|94404|94404|04/09/2018|09/24/2018|SESE|RA|LLZ|Summary|RA||Traditional|N||iNtuition-T1 Mapping and T2/T2* Mapping K180919|W.L. Gore and Associates Inc.|Michael Ivey|1505 N. Fourth St.||Flagstaff|AZ|US|86005|86005|04/09/2018|10/05/2018|SESE|CV|DQY|Summary|CV||Traditional|N||GORE Tri-Lumen Catheter K180933|Medtech Products Inc.|Mary Beth Fritz|660 White Plains Rd|Suite 250|Tarrytown|NY|US|10591|10591|04/10/2018|09/17/2018|SESE|DE|OBR|Summary|||Traditional|N||DenTek Ultimate Dental Guard K180964|Intuitive Surgical, Inc.|Kunal Gunjal|1266 Kifer Road, Building 101||Sunnyvale|CA|US|94086|94086|04/12/2018|09/28/2018|SESE|HO|KCT|Summary|HO||Traditional|N||Endoscope Sterilization Tray K180972|Jeil Medical Corporation|Seungyong Lee|702,703,704,705,706,804,805,807,812,815-ho,55|Digital-ro34-gil, Guro-gu|Seoul||KR|08378|08378|04/13/2018|10/03/2018|SESE|OR|HRS|Summary|OR||Traditional|N||ARIX Clavicle System K180973|Maxx Orthopedics, Inc|Corey Perine|531 Plymouth Road, Suite 526||Plymouth Meeting|PA|US|19462|19462|04/13/2018|09/28/2018|SESE|OR|JDI|Summary|OR||Traditional|N||Libertas Hip Replacement System K180981|Stimwave Technologies Incorporated|Elizabeth Greene|1310 Park Central Boulevard South||Pompano Beach|FL|US|33064|33064|04/13/2018|09/19/2018|SESE|NE|GZB|Summary|NE||Traditional|N||Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit K180991|Hospitech Respiration Ltd.|Yoram Levy|20 Hamagshimim St. Kiryat Matalon||Petach Tikva||IL|49348|49348|04/16/2018|10/12/2018|SESE|AN|BSK|Summary|AN||Traditional|N||AG 100s K180998|BioHorizons Implant Systems, Inc.|Michael Davis|2300 Riverchase Center||Birmingham|AL|US|35244|35244|04/16/2018|09/28/2018|SESE|DE|NHA|Summary|DE||Traditional|N||BioHorizons CAD/CAM Bars K181000|Q'Apel|Ken Peartree|330 Wilshire Boulevard||Santa Monica|CA|US|90401|90401|04/16/2018|09/13/2018|SESE|NE|DQY|Summary|CV||Traditional|N||SelectFlex 072 Neurovascular Access System K181006|Bio-Beat Technologies Ltd.|Johanan May|26 Magshimim Street||Petach Tikvah||IL|4934835|4934835|04/16/2018|09/21/2018|SESE|AN|DQA|Summary|CV||Traditional|N||BB-613 Watch Oximeter K181008|Carol Cole Company dba NuFACE|Donald Ellis|1325 Sycamore Ave. Suite A||Vista|CA|US|92081|92081|04/17/2018|10/11/2018|SESE|NE|NFO|Summary|NE||Traditional|N||NuFACE Plus K181021|Biosphere Medical, S.A.|Alix Fonlladosa|Parc des Nations – Paris Nord 2, 383 rue de la Belle Etoile||Roissy en France||FR|95700|95700|04/17/2018|09/27/2018|SESE|CV|KRD|Summary|CV||Traditional|N||EmboCube Embolization Gelatin K181034|Hadleigh Health Technologies, LLC|Robert Miros|30 Castro Ave.||San Rafael|CA|US|94901|94901|04/18/2018|09/21/2018|SESE|OB|HEX|Summary|OB||Traditional|N||Pocket Colposcope System K181038|CorMatrix Cardiovascular, Inc.|Wendy Perreault|1100 Old Ellis Rd.||Roswell|GA|US|30076|30076|04/19/2018|10/10/2018|SESE|CV|DXZ|Summary|CV||Traditional|N||CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) K181061|Corin USA|Lucinda Gerber|12750 Citrus Park Lane, Suite 120||Tampa|FL|US|33625|33625|04/23/2018|09/07/2018|SESE|OR|LZO|Summary|OR||Traditional|N||Corin Optimized Positioning System (OPS) Femoral K181066|ECO Medi Glove Sdn Bhd|Suresh Kumar|Lot 23826, Jalan Tembaga Kuning|Kamunting Raya Industrial Estate|Perak||MY|34600|34600|04/23/2018|09/26/2018|SESE|HO|LZA|Summary|HO||Traditional|N||Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims K181075|Nobel Biocare AB|Charlemagne Chua|BOX 5190, SE-402 26, Vastra Hamngatan 1||Goteborg||SE|SE-411 17|SE-411 17|04/24/2018|09/27/2018|SESE|HO|KCT|Summary|HO||Traditional|N||PureSet Tray K181078|Necessaire, Inc.|Randi Christiansen Stanley|10 Arbolo Court||Manhattan Beach|CA|US|90266|90266|04/24/2018|09/10/2018|SESE|OB|NUC|Summary|OB||Traditional|N||The Sex Gel K181081|Joytech Healthcare Co., Ltd.|Ren Yunhua|No.365, Wuzhou Road, Yuhang Economic Development Zone|Hangzhou City|Hangzhou||CN|311100|311100|04/24/2018|10/02/2018|SESE|HO|FLL|Summary|HO||Traditional|N||Infrared Ear Thermometer K181088|Transseptal Solutions Ltd.|Mary P. LeGraw|10 HaGavish St., P.O. Box 4060||Natanya||IL|4250708|4250708|04/25/2018|09/28/2018|SESE|CV|DYB|Summary|CV||Traditional|N||TSP Crosser Transseptal Access System K181091|Stryker GmbH|Saad Attiyah|Bohnackerweg 1||Selzach||CH|2545|2545|04/24/2018|10/11/2018|SESE|OR|HRS|Summary|OR||Traditional|N||AxSOS 3 Ti K181102|Pfizer Inc.|Nicola Romano|235 East 42nd Street||New York|NY|US|10017|10017|04/26/2018|09/15/2018|SESE|NE|NUH|Summary|NE||Traditional|N||ThermaCare Quick Therapy TENS K181124|Acessa Health, Inc.|Brian J. Bergeron|7004 Bee Cave Road, Bldg 3, Suite 200||Austin|TX|US|78746|78746|04/30/2018|09/28/2018|SESE|OB|HFG|Summary|OB||Traditional|N||Acessa ProVu System K181128|Contego Medical, LLC|Elizabeth Saylors|3921 Sunset Ridge Rd, Suite 102||Raliegh|NC|US|27607|27607|04/30/2018|09/06/2018|SESE|CV|LIT|Summary|CV||Traditional|N||Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) K181138|Neobiotech Co., Ltd.|Young-Ku Heo|#312-1, 36, Digital-ro 27-Gil, Guro-gu||Seoul||KR|08381|08381|04/30/2018|10/03/2018|SESE|DE|DZE|Summary|DE||Traditional|N||IS-III active System K181167|Liaoning Upcera Co., Ltd|Charles Shen|No.122 Xianghuai Road, Economic Development Zone||Benxi||CN|117004|117004|05/02/2018|09/02/2018|SESE|DE|EIH|Summary|DE||Traditional|N||Upcera Glaze Paste, Glaze Powder, and Glaze Liquid K181196|Caretaker Medical, LLC|Jeff Pompeo|941 Glenwood Station Ln, Suite 301||Charlottesville|VA|US|22901|22901|05/07/2018|10/03/2018|SESE|CV|DRG|Summary|CV||Traditional|N||Caretaker Remote Display App and Caretaker Software Library K181199|Katalyst Inc.|Bjoern Woltermann|316 Occidental Ave.|South Suite B300|Seattle|WA|US|98104|98104|05/07/2018|09/20/2018|SESE|PM|NGX|Summary|PM||Traditional|N||Katalyst Mark 1 Muscle Stimulation System Model 2 K181200|Merit Medical Systems, Inc|David Thomas|1600 West Merit Parkway||South Jordan|UT|US|84095|84095|05/07/2018|09/21/2018|SESE|AN|JCT|Summary|SU||Traditional|N||AEROmini Tracheobronchial Stent System K181205|Centers for Disease Control and Prevention|Yon Yu|1600 Clifton Road NE, MS-C18||Atlanta|GA|US|30329|30329|05/07/2018|09/20/2018|SESE|MI|PBK|Summary|MI||Traditional|N||Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set K181211|UNIBELL S.r.l|Mario Scerri|Via Indipendenza, 27||Calco||IT|23885|23885|05/07/2018|09/10/2018|SESE|SU|PBX|Statement|SU||Traditional|N||Human Tecar HCR 1002 K181220|Park Dental Research Corporation|Ronald A Bulard|2401 N. Commerce Street Suite E||Ardmore|OK|US|73401|73401|05/07/2018|10/12/2018|SESE|DE|EBI|Summary|DE||Traditional|N||Juell 3D Volo Base K181229|Captiva Spine, Inc.|Jackie Ferro|967 N. Alternate A1A, Ste. 1||Jupiter|FL|US|33477|33477|05/09/2018|09/19/2018|SESE|OR|ODP|Summary|OR||Traditional|N||TirboLOX-C Cervical IBFD K181233|Roche Diagnostics|Reanna Toney|9115 Hague Road||Indianapolis|IN|US|46250|46250|05/09/2018|09/18/2018|SESE|CH|CEC|Summary|CH||Traditional|N||Elecsys FT4 III K181236|OSSTEM IMPLANT CO LTD|Jungmin Yoo|203, GEOJE-DAERO YEONJE-GU||BUSAN||KR|611-804|611-804|05/10/2018|09/13/2018|SESE|DE|ELW|Summary|DE||Traditional|N||HySil Impression Materials K181240|Olympus Medical Systems Corp.|Toshiyuki Nakajima|2951 Ishikawa-cho||Hachioji-Shi||JP|192-8507|192-8507|05/10/2018|10/04/2018|SESE|EN|EOB|Summary|EN||Traditional|N||Rhino-Laryngo Fiberscope Olympus ENF-GP2 K181241|KLS-Martin L.P.|Jennifer Damato|11201 Saint Johns Industrial Pkwy S||Jacksonville|FL|US|32246|32246|05/10/2018|09/13/2018|SESE|DE|DZJ|Summary|DE||Traditional|N||KLS Martin Individual Patient Solutions (IPS) Planning System K181249|STARmed Co., Ltd.|Jun-Young Jung|B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu||Goyang-si||KR|10355|10355|05/10/2018|09/04/2018|SESE|SU|GEI|Summary|SU||Traditional|N||EUSRA RF Electrode K181255|Wright Medical Technology, Inc.|Rachel Roberts|1023 Cherry Road||Memphis|TN|US|37117|37117|05/11/2018|09/12/2018|SESE|OR|MQV|Summary|OR||Traditional|N||PRODENSE Bone Graft Substitute K181270|Orantech Inc.|Yunxi Xiong|Zone#A, 4F, 1st Bld, 7th Industrial Zone, Yulv Community,|GongMing|Shenzhen||CN|518132|518132|05/14/2018|09/07/2018|SESE|AN|DQA|Summary|CV||Traditional|N||Disposable SpO2 Sensors, Reusable SpO2 Sensors K181277|Alpinion Medical Systems Co., Ltd.|Boyeon Cho|1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu||Seoul||KR|08393|08393|05/14/2018|09/28/2018|SESE|RA|IYN|Summary|RA||Traditional|N||E-CUBE 12 K181305|Premier Biotech, Inc.|Jacqueline Gale|723 Kasota Avenue SE||Minneapolis|MN|US|55414|55414|05/17/2018|09/20/2018|SESE|TX|DJC|Summary|TX||Traditional|N||OralTox Oral fluid Drug Test K181311|Philips Medical Systems Nederlands B.V.|Owen Callaghan|Veenpluis 4-6||Best||NL|5684PC|5684PC|05/17/2018|09/07/2018|SESE|CV|MWI|Summary|CV||Abbreviated|N||Philips Hemodynamic Application R1.0 K181314|Philips Medizin Systeme Boeblingen GmbH|Stefan Breuer|Hewlett-Packard-Str. 2||Boeblingen||DE|71034|71034|05/17/2018|09/04/2018|SESE|CV||Summary|||Traditional|N||IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension K181320|Resorba Medical GmbH|Helen Topping|Am Flachmoor 16||Nuremberg||DE|90475|90475|05/18/2018|09/18/2018|SESE|SU|GAM|Summary|SU||Traditional|N||Caprolon K181322|Siemens Medical Solutions USA, Inc.|Cordell L. Fields|65 Valley Stream Parkway 65-1A||Malvern|PA|US|19355|19355|05/18/2018|10/05/2018|SESE|RA|LNH|Summary|RA||Traditional|N||MAGNETOM Sola K181328|Medtronic Sofamor Danek, USA Inc.|Kanesha Hines|1800 Pyramid Place||Memphis|TN|US|38132|38132|05/18/2018|09/19/2018|SESE|OR|MQP|Summary|OR||Traditional|N||T2 STRATOSPHERE™ Expandable Corpectomy System K181330|NeXtGen Biologics, Inc.|Jonelle L. Toothman|747 SW 2nd Ave - IMB 5||Gainesville|FL|US|32601|32601|05/18/2018|10/11/2018|SESE|SU|KGN|Summary|||Traditional|N||NeoMatriX Wound Matrix K181337|Biogennix, LLC|Tim Bumbalough|18007 Sky Park Circle, Suite f||Irvine|CA|US|92614|92614|05/21/2018|09/18/2018|SESE|OR|MAX|Summary|OR||Traditional|N||Sypher Spacer System K181349|Visco Vision Inc|Evan Huang|No. 1, Xingye St., Guishan Dist.,||Taoyuan City||TW|33341|33341|05/21/2018|09/19/2018|SESE|OP|LPL|Summary|OP||Traditional|N||Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens K181366|Smith & Nephew, Inc.|Bryan Cowell|7135 Goodlett Farms Parkway||Cordova|TN|US|38016|38016|05/23/2018|09/24/2018|SESE|OR|LPH|Summary|OR||Traditional|N||REDAPT Porous Acetabular Shell K181370|Shanghai United Imaging Healthcare Co., Ltd.|Xin GAO|No. 2258 Chengbei Rd., Jiading Industrial District||Shanghai||CN|201807|201807|05/23/2018|10/03/2018|SESE|RA|LNH|Summary|RA||Traditional|N||uMR 780 K181371|Shanghai United Imaging Healthcare Co.,Ltd.|Xin GAO|No. 2258 Chengbei Rd., Jiading Industrial District||Shanghai||CN|201807|201807|05/23/2018|10/03/2018|SESE|RA|LNH|Summary|RA||Traditional|N||uMR 790 K181380|L&K BIOMED Co., Ltd.|Jihyeon Seo|#201, 202, 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu||Yongin-si||KR|17015|17015|05/24/2018|09/11/2018|SESE|OR|MAX|Summary|OR||Traditional|N||LnK Lumbar Interbody Fusion Cage System K181390|OrthoPediatrics, Corp|Mark Fox|2850 Frontier Drive||Warsaw|IN|US|46582|46582|05/29/2018|09/18/2018|SESE|OR|NKB|Summary|OR||Traditional|N||Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System K181397|Innovasive, Inc.|Andy Choi|26020 Acero, Ste 200||Mission Viejo|CA|US|92691|92691|05/29/2018|09/27/2018|SESE|OR|MAX|Summary|OR||Traditional|N||DualX K181415|Canon Medical Systems Corporation|Paul Biggins|1385 Shimoishigami||Otawara-shi||JP|324-8550|324-8550|05/30/2018|09/10/2018|SESE|RA|OWB|Summary|RA||Traditional|N||XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 K181420|Tornier, Inc.|Laurie Lewandowski|10801 Nesbitt Ave South||Bloomington|MN|US|55437|55437|05/31/2018|09/20/2018|SESE|OR|KWS|Summary|OR||Traditional|N||Aequalis Flex Revive Shoulder System K181423|Amsino International Inc.|Jane Gao|708 Corporate Center Drive||Pomona|CA|US|91768|91768|05/31/2018|09/07/2018|SESE|SU|FRO|Summary|||Traditional|N||AMSure Sterile Water, and Sterile Normal Saline for Wound Flush K181424|PeDIA, LLC|Diane Miller|2804 Albany Court||Fairfax|VA|US|22031|22031|05/31/2018|09/25/2018|SESE|AN|BTC|Summary|AN||Traditional|N||PeDIA K181426|Jiangsu Micsafe Medical Technology Co., Ltd|Tony Yang|Xituan Industrial Park, Dafeng District||Yancheng||CN|224125|224125|05/31/2018|10/11/2018|SESE|GU|PNR|Summary|GU||Traditional|N||Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) K181445|Amsino International Inc.|Zoe Wu|708 Corporate Center Drive||Pomona|CA|US|91768|91768|06/01/2018|10/01/2018|SESE|GU|EZD|Summary|GU||Traditional|N||AMSure Hydrophilic Intermittent Catheter K181449|Ortoma AB|Linus Bystrom|Vadursgatan 5||Goteborg||SE|S-41250|S-41250|06/01/2018|09/19/2018|SESE|OR|OLO|Summary|NE||Traditional|N||Ortoma Treatment Solution - OTS K181455|ProSun International LLC|Tom Henkemans|2442 23rd Street North||Saint Petersburg|FL|US|33713|33713|06/04/2018|09/10/2018|SESE|SU|LEJ|Summary|SU||Traditional|N||ProSun sunlamp products, Luxura sunlamp products K181460|OnePacs, LLC|Justin Falk|530 Lytton Ave||Palo Alto|CA|US|94301|94301|06/04/2018|10/11/2018|SESE|RA|LLZ|Summary|RA||Traditional|N||OnePacs System K181466|Cadwell Industries, Inc.|Alison Hull|909 North Kellogg Street||Kennewick|WA|US|99336|99336|06/04/2018|09/01/2018|SESE|NE|GWQ|Summary|NE||Traditional|N||Cadwell Zenith System K181476|Dentsply Sirona|Karl Nittinger|221 West Philadelphia Street, Suite 60W||York|PA|US|17401|17401|06/05/2018|09/28/2018|SESE|DE|KLE|Summary|DE||Traditional|N||Prime&Bond active Universal Adhesive K181503|Beijing Choice Electronic Technology Co., Ltd.|Haiying Zhao|No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan|District|Beijing||CN|100041|100041|06/07/2018|10/11/2018|SESE|AN|DQA|Summary|CV||Traditional|N||Fingertip Pulse Oximeter K181504|Stryker|Gregory Gohl|750 Trade Centre Way - Suite 200||Portage|MI|US|49002|49002|06/07/2018|09/11/2018|SESE|DE|MQN|Summary|DE||Traditional|N||Stryker Pediatric Mandibular Distractor 2 K181510|El.En Electronic Engineering Spa|Paolo Peruzzi|Via Baldanzese 17||Calenzano||IT|50041|50041|06/08/2018|09/04/2018|SESE|SU|GEX|Summary|SU||Traditional|N||ECHOLASER X4 K181517|TransEnterix, Inc.|Kaitlyn Alexander|635 Davis Drive, Suite 300||Morrisville|NC|US|27560|27560|06/08/2018|10/09/2018|SESE|SU|NAY|Summary|GU||Traditional|N||Senhance Surgical System K181518|Sebacia, Inc.|Todd J. Meyer|2905 Premiere Parkway, Suite 150||Duluth|GA|US|30097|30097|06/08/2018|09/06/2018|SESE|SU|QCY|Summary|SU||Traditional|N||Sebacia Microparticles K181520|Dentsply Sirona|Karl J. Nittinger|221 West Philadelphia St., Suite 60W||York|PA|US|17401|17401|06/11/2018|10/11/2018|SESE|DE|NHA|Summary|DE||Traditional|N||Sirona Dental CAD/CAM System K181525|Siemens Healthcare Diagnostics Products GmbH|Petra Dissmann|Emil-von-Behring Strasse 76||Marburg||DE|35041|35041|06/11/2018|09/07/2018|SESE|HE|GGP|Summary|HE||Traditional|N||INNOVANCE Free PS Ag K181527|ACON Laboratories, Inc.|Qiyi Xie|10125 Mesa Rim Road||San Diego|CA|US|92121|92121|06/11/2018|10/03/2018|SESE|CH|NBW|Summary|CH||Traditional|N||On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System K181531|SpineEX Inc.|Andrew Rogers|4046 Clipper Court||Fremont|CA|US|94538|94538|06/11/2018|10/05/2018|SESE|OR|MAX|Summary|OR||Traditional|N||SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices K181532|Exactech, Inc.|Zach Sharrah|2320 NW 66th Court||Gainesville|FL|US|32653|32653|06/11/2018|09/04/2018|SESE|OR|LZO|Summary|OR||Special|N||Exactech Alteon Monobloc Revision Stem K181537|Leica Microsystems (Schweiz) AG|Georges Hakim|Max Schmidheiny-Strasse 201||Heerbrugg||CH|9435|9435|06/11/2018|09/07/2018|SESE|NE|IZI|Summary|RA||Traditional|N||GLOW800 K181539|OssDsign AB|Ulrik Birgersson|Virdings Alle 2||Uppsala||SE|SE 754 50|SE 754 50|06/11/2018|10/12/2018|SESE|NE|GXR|Summary|NE||Traditional|N||OSSDSIGN Cranioplug K181558|Gelflex Laboratories|David Masel|52 Mulgul Road||Malaga||AU|6090|6090|06/13/2018|09/06/2018|SESE|OP|LPL|Summary|OP||Traditional|N||Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens K181563|Access Scientific, LLC|Martina Nguyen|3910 Sorrento Valley Boulevard, Suite 200||San Diego|CA|US|92121|92121|06/14/2018|09/26/2018|SESE|CV|DQY|Summary|CV||Traditional|N||The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology K181568|Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt|Bruce Wu|4th Floor of Building #1, No.228, Jiaosong Road|Taiwanese Investment Zone|Zhangzhou||CN|||06/14/2018|09/11/2018|SESE|SU|OHT|Summary|SU||Traditional|N||IPL Salon Hair Reduction System K181569|Ortho Development Corporation|Dan Petersen|12187 So. Business Park Drive||Draper|UT|US|84020|84020|06/14/2018|10/12/2018|SESE|OR|JWH|Summary|OR||Traditional|N||BKS Revision Sleeves System K181576|Planmeca Oy|Lars Moring|Asentajankatu 6||Helsinki||FI|00880|00880|06/15/2018|09/13/2018|SESE|RA|OAS|Summary|RA||Traditional|N||Planmeca Viso K181578|Demetech Corporation|Linda Hernandez|14175 NW 60th Ave.||Miami Lakes|FL|US|33104|33104|06/15/2018|10/11/2018|SESE|SU|NBY|Summary|SU||Traditional|N||DemeTECH PTFE Nonabsorbable Surgical Suture K181587|Tornier Inc.|Renee Stoffel|10801 Nesbitt Ave South||Bloomington|MN|US|55437|55437|06/15/2018|10/05/2018|SESE|OR|HRS|Summary|OR||Traditional|N||ORTHOLOC SPS Shoulder Plating System K181591|Medical Designs, LLC|Kristi Vondra|6709 S. Minnesota Ave, Suite 204||Sioux Falls|SD|US|57108|57108|06/18/2018|09/26/2018|SESE|OR|MAX|Summary|OR||Traditional|N||Fixated Asfora BULLET CAGE® (FABC) K181594|Heidelberg Engineering GmbH|Christoph Schoess|Max-Jarecki-Strasse 8||Heidelberg||DE|69115|69115|06/18/2018|09/13/2018|SESE|OP|OBO|Summary|OP||Traditional|N||Spectralis HRA+OCT and variants with OCT Angiography Module K181598|MicroPort Orthopedics Inc.|Sarah Evonne Stroupe|5677 Airline Road||Arlington|TN|US|38002|38002|06/18/2018|09/14/2018|SESE|OR|LZO|Summary|OR||Traditional|N||Prime E-CLASS XLPE Liner K181603|K2M Inc.|Nancy Giezen|600 Hope Pkwy. SE||Leesburg|VA|US|20175|20175|06/19/2018|10/05/2018|SESE|OR|NKG|Summary|||Traditional|N||EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System K181607|A&E Medical Corporation|Dana Rodriguez|5206 Asbury Road, PO Box 758||Farmingdale|NJ|US|07727|07727|06/19/2018|10/12/2018|SESE|OR|JDQ|Summary|OR||Traditional|N||Thorecon Rigid Fixation System K181608|Standard Bariatrics|Alison Sathe|4362 Glendale Milford Rd.||Cincinnati|OH|US|45242|45242|06/19/2018|09/27/2018|SESE|SU|GCJ|Summary|GU||Traditional|N||Disposable Standard Clamp K181611|Biomet Manufacturing Corp|Dalene Binkley|56 East Bell Drive||Warsaw|IN|US|46580|46580|06/19/2018|09/24/2018|SESE|OR|PHX|Summary|OR||Traditional|N||Comprehensive Reverse Shoulder System K181616|Pathway, LLC|David Stroup|8779 Cottonwood Avenue, Suite 105||Santee|CA|US|92071|92071|06/19/2018|09/21/2018|SESE|GU|EZL|Summary|GU||Traditional|N||PSM 3-Way Silicone Foley Catheter K181617|Alpinion Medical Systems Co., Ltd.|Boyeon CHO|1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu||Seoul||KR|08393|08393|06/19/2018|10/11/2018|SESE|RA|IYN|Summary|RA||Traditional|N||E-CUBE 8 K181620|Ezisurg (Suzhou) Medical Co., Ltd.|Renjing Tian|Building 16, No. 8 Jinfeng Rd.,|Suzhou National Hi-Tech District|Suzhou||CN|215163|215163|06/20/2018|09/18/2018|SESE|SU|GDW|Summary|SU||Traditional|N||Endoscopic Linear Cutting Staplers and Loading Units for Single Use K181622|Medtronic Neurosurgery|Xiaojian Sun|125 Cremona Dr||Goleta|CA|US|93117|93117|06/20/2018|10/01/2018|SESE|NE|JXG|Summary|NE||Traditional|N||StrataMR guider tool K181632|Quanta System Spa|Francesco Dell'Antonio|Via Acquedotto 109||Samarate (Va)||IT|21017|21017|06/20/2018|09/17/2018|SESE|SU|GEX|Statement|SU||Traditional|N||Venacure 1470 Pro K181640|X-Bolt Orthopaedics|Brian Thornes|Unit 5 Northwood Court Santry, Dublin 9||Dublin||IE|||06/21/2018|10/12/2018|SESE|OR|HSB|Summary|OR||Traditional|N||X-BOLT Hip Fracture Fixation System K181642|Eximo Medical Ltd.|Yossi Muncher|3 Pekeris St.||Rehovot||IL|7670203|7670203|06/21/2018|10/05/2018|SESE|CV|MCW|Summary|CV||Traditional|N||B-Laser Atherectomy System K181644|EIT Emerging Implant Technologies GmbH|Barbara Wirth|Eisenbahnstrasse 83||Wurmlingen||DE|78573|78573|06/22/2018|10/12/2018|SESE|OR|MAX|Summary|OR||Traditional|N||EIT Cellular Titanium® Lumbar Cage LLIF K181651|Radial Medical, Inc.|Eric Johnson|2500 Grant Road||Mountain View|CA|US|94040|94040|06/22/2018|10/12/2018|SESE|CV|JOW|Summary|CV||Traditional|N||Radial Medical Compression System K181652|Ethicon, Inc.|Donna Marshall|Route 22 West, P.O. Box 151||Somerville|NJ|US|08876-0151|08876-0151|06/22/2018|09/28/2018|SESE|SU|GAM|Summary|SU||Traditional|N||Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture K181653|Ethicon Endo-Surgery, LLC|Sigfrido Delgado|475 Calle C||Guaynabo|PR|US|00969|00969|06/22/2018|09/18/2018|SESE|SU|GDW|Summary|SU||Traditional|N||Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed K181655|Renovis Surgical Technologies|Anthony Debenedictis|1901 W. Lugonia||Redlands|CA|US|92374|92374|06/22/2018|09/11/2018|SESE|OR|MAX|Summary|OR||Traditional|N||Renovis S180 Lateral Lumbar Interbody Fusion System K181662|Iridex Corporation|Edward J. Sinclair|1212 Terra Bella Avenue||Mountain View|CA|US|94043|94043|06/25/2018|09/05/2018|SESE|OP|GEX|Summary|SU||Special|N||Iridex TruFocus LIO Premiere K181665|Becton,Dickinson and Company|Monica E. Giguere|7 Loveton Circle MC 694||Sparks|MD|US|21152|21152|06/25/2018|09/21/2018|SESE|MI|LON|Summary|MI||Traditional|N||BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN K181688|Shenzhen Roundwhale Technology Co., Ltd.|Kevin Zhang|No. 615, Building C of Sanlian Industrial Zone, Shiyan|Baoan District|Shenzhen||CN|518108|518108|06/26/2018|09/07/2018|SESE|PM|IPF|Summary|PM||Traditional|N||R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator K181692|Health Beacons, Inc.|Nancy Confrey|34 Walden St., #753||Concord|MA|US|01742|01742|06/27/2018|09/25/2018|SESE|SU|NEU|Summary|SU||Traditional|N||5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) K181702|Nexus Spine, LLC|Jared Crocker|2825 E Cottonwood Parkway, Suite 330||Salt Lake City|UT|US|84121|84121|06/27/2018|09/21/2018|SESE|OR|MAX|Summary|OR||Traditional|N||Tranquil-L Interbody System K181707|Everyway Medical Instruments Co., Ltd.|Paul Hung|3Fl., No. 5, Lane 155, Section 3, Peishen Rd.,||Shenkeng District, New Taipei City||TW|22203|22203|06/28/2018|09/26/2018|SESE|NE|NUH|Statement|NE||Traditional|N||Everyway Wireless TENS & EMS Unit K181717|Life Spine Inc.|Angela Batker|13951 S Quality Drive||Huntley|IL|US|60142|60142|06/28/2018|10/12/2018|SESE|OR|NQW|Summary|OR||Traditional|N||Life Spine Laminoplasty System K181721|curasan AG|Gregor Thomas|Lindigstrasse 4||Kleinostheim||DE|63801|63801|06/29/2018|09/17/2018|SESE|OR|MQV|Summary|OR||Traditional|N||Ceracell Ortho Foam K181725|Avenu Medical, Inc.|Rebecca K. Pine|27123 Calle Arroyo, Suite 2101||San Juan Capistrano|CA|US|92675|92675|06/29/2018|10/05/2018|SESE|CV|PQK|Summary|CV||Traditional|N||Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) K181726|Medline Industries, Inc.|Dinah Rincones|Three Lakes Drive||Northfield|IL|US|60093|60093|06/29/2018|09/20/2018|SESE|CV|DSA|Summary|CV||Traditional|N||Medline Patient Cables and Lead Wires K181734|Home Well Trading LTD|Martin Gurovich|Omar Hodge Building, Road Town||Tortola||VG|||07/02/2018|09/19/2018|SESE|SU|OHT|Summary|SU||Traditional|N||Beurer IPL 8500 device/ IPL VelvetSkin Pro K181742|Stryker GmbH|Tina Mornak|325 Corporate Drive||Mahwah|NJ|US|07430|07430|07/02/2018|09/27/2018|SESE|OR|KWS|Summary|OR||Traditional|N||ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) K181746|Smith and Nephew, Inc.|Katherine Marcaccio|7135 Goodlett Farms Parkway||Cordova|TN|US|38016|38016|07/02/2018|09/28/2018|SESE|OR|MAI|Summary|OR||Traditional|N||MICRORAPTOR Knotless Suture Anchor K181748|Abbott Laboratories|Mark Littlefield|1921 Hurd Drive||Irving|TX|US|75038|75038|07/02/2018|09/12/2018|SESE|CH|JGJ|Summary|CH||Traditional|N||Magnesium K181769|Arthrex, Inc.|David L. Rogers|1370 Creekside Boulevard||Naples|FL|US|34108-1945|34108-1945|07/03/2018|09/21/2018|SESE|OR|MBI|Summary|OR||Traditional|N||Arthrex FiberTak Suture Anchor K181771|RightEye, LLC|Adam Gross|7979 Old Georgetown Rd., Suite 801||Bethesda|MD|US|20814|20814|07/03/2018|09/28/2018|SESE|OP|GWN|Summary|NE||Traditional|N||RightEye Vision System K181773|FUJIFILM Corporation|Randy Vader|798 Miyanodai Kaisei-Machi||Ashigarakami-Gun||JP|258-8538|258-8538|07/03/2018|09/25/2018|SESE|RA|LLZ|Summary|RA||Traditional|N||Synapse 3D Optional Tools K181774|Teleflex Medical Incorporated|Andrea Curria|375 Forbes Boulevard||Mansfield|MA|US|02048|02048|07/03/2018|10/10/2018|SESE|SU|GAT|Summary|SU||Traditional|N||Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture K181783|GE Healthcare|Bryan Behn|9900 Innovation Drive||Wauwatosa|WI|US|53226|53226|07/03/2018|09/20/2018|SESE|RA|IYN|Summary|RA||Traditional|N||LOGIQ P9; LOGIQ P7 K181789|MedCom GmbH|Johannes Messow|Dolivostrasse 11||Darmstadt||DE|64293|64293|07/05/2018|09/21/2018|SESE|RA|LHN|Summary|RA||Abbreviated|N||VeriSuite K181794|Exactech, Inc.|Patrick Hughes|2320 NW 66th CT||Gainesville|FL|US|32653|32653|07/05/2018|09/28/2018|SESE|OR|MBH|Summary|OR||Special|N||Truliant Porous Femoral Components K181795|Sichuan AST Medical Equipment Co., Ltd.|Johnson Van|No.58, Jin-Peng Road, C Area, Luxian Industrial Park||Luzhou City||CN|646100|646100|07/05/2018|09/25/2018|SESE|PM|IOR|Summary|PM||Traditional|N||AST Model MA012 and MS019 Rehab Wheelchair K181811|Coloplast A/S|Cori Ragan|1601 West River Road North||Minneapolis|MN|US|55411|55411|07/06/2018|09/07/2018|SESE|GU|FED|Summary|GU||Special|N||ReTrace Ureteral Access Sheath K181814|Amsino International, Inc.|Cathy Hong|708 Corporate Center Drive||Pomona|CA|US|91768|91768|07/09/2018|09/04/2018|SESE|GU|EZL|Summary|GU||Traditional|N||AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water K181818|Spineart|Franck Pennesi|3 Chemin du Pré Fleuri||Plan Les Ouates||CH|1228|1228|07/09/2018|10/09/2018|SESE|OR|OVD|Summary|OR||Traditional|N||Scarlet AL-T K181821|Biedermann Motech GmbH & Co. KG|Gerd Federle|Bertha-von-Suttner-Strasse 23||Villingen-Schwenningen||DE|78054|78054|07/09/2018|09/13/2018|SESE|OR|NKB|Summary|OR||Traditional|N||MOSS VRS Spinal System K181848|Stryker GMBH|Tina Mornak|325 Corporate Drive||Mahwah|NJ|US|07430|07430|07/11/2018|10/12/2018|SESE|OR|OLO|Summary|NE||Traditional|N||ADAPT for Gamma3, Gamma3 K181852|Teleflex Medical, Inc.|Kim Campbell|3015 Carrington Mill Blvd||Morrisville|NC|US|27560|27560|07/11/2018|10/12/2018|SESE|SU|GEI|Summary|SU||Traditional|N||Percuvance Percutaneous Surgical System K181860|NuVasive, Incorporated|Olga Lewis|7475 Lusk Blvd.||San Diego|CA|US|92121|92121|07/12/2018|10/05/2018|SESE|OR|MAX|Summary|OR||Traditional|N||NuVasive Cohere Thoracolumbar Interbody System K181863|Chiaro Technology Limited|Jonathan O'Toole|2nd Floor 63-66 Hatton Garden||London||GB|EC1N 8LE|EC1N 8LE|07/12/2018|10/10/2018|SESE|OB|HGX|Summary|OB||Traditional|N||Elvie Pump K181867|El.En Electronic Engineering Spa|Paolo Peruzzi|Via Baldanzese 17||Calenzano||IT|50041|50041|07/12/2018|10/02/2018|SESE|SU|GEX|Summary|SU||Special|N||Deka Smartxide2 Trio K181868|IDS, Ltd.|C.J. Park|#105, Byoksan Digital Valley 3 cha 271, Digital-ro, Guro-gu||Seoul||KR|08381|08381|07/12/2018|10/05/2018|SESE|SU|ONF|Summary|SU||Traditional|N||SHINY RPL System K181874|Huestis Machine Corporation|Frederick M. Correira|68 Buttonwood Street||Bristol|RI|US|02809|02809|07/13/2018|09/14/2018|SESE|RA|IZL|Summary|RA||Traditional|N||MX40 Mobile Digital X-ray System K181878|Kiierr International, LLC|Michael Anderson|863 East Downington Avenue||Salt Lake City|UT|US|84105-3211|84105-3211|07/13/2018|09/05/2018|SESE|SU|OAP|Summary|PM||Traditional|N||Kiierr 272 Laser, Kiierr 148 Laser K181881|SIJ Surgical|Daniel Hoehn|6829 Falls of Neuse Rd., Ste 103||Raleigh|NC|US|27615|27615|07/13/2018|10/03/2018|SESE|OR|OUR|Summary|OR||Traditional|N||Outlet Sacroiliac Joint Fusion System K181883|Mighty Oak Medical Inc.|Mark A. Wylie|750 W. Hampden Avenue, Suite 120||Englewood|CO|US|80110|80110|07/13/2018|10/03/2018|SESE|OR|PQC|Summary|OR||Traditional|N||FIREFLY® Midline Navigation Guide K181885|Viseon, Inc.|Cora Sim|13900 Alton Parkway, Suite 125||Irvine|CA|US|92618|92618|07/13/2018|10/02/2018|SESE|SU|HRX|Summary|OR||Traditional|N||Voyant System K181889|Liofilchem s. r. l.|Fabio Brocco|Via Scozia zona ind.le||Roseto degli Abruzzi||IT|64026|64026|07/13/2018|09/13/2018|SESE|MI|JWY|Statement|MI||Traditional|N||MTS Penicillin 0.002- 32 µg/mL K181892|Ziosoft, Inc.|Tsuyoshi Nagata|MitaKokusai Bldg., 1-4-28 Mita||Minato-ku||JP|108-0073|108-0073|07/13/2018|10/09/2018|SESE|RA|LLZ|Summary|RA||Traditional|N||Ziostation2 K181903|Varian Medical Systems, Inc.|Peter J. Coronado|3100 Hansen Way||Palo Alto|CA|US|94304|94304|07/16/2018|10/03/2018|SESE|RA|JAQ|Summary|RA||Traditional|N||BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device K181904|Piper Access LLC|Jay Muse|3981 South 700 East Suite 15||Salt Lake City|UT|US|84107|84107|07/16/2018|09/25/2018|SESE|HO|LJS|Summary|HO||Traditional|N||5 FR Dual Lumen Piper PICC K181926|Anatomage Inc.|Changxin Xu|303 N. Almaden Blvd. Suite 700||San Jose|CA|US|95110|95110|07/18/2018|09/21/2018|SESE|RA|LLZ|Summary|RA||Traditional|N||InVivo Web Viewer K181949|Medos International SARL|Sheree Geller|Chemin-Blanc 38||Le Locle||CH|2400|2400|07/20/2018|10/04/2018|SESE|OR|NKG|Summary|||Traditional|N||SYMPHONY™ OCT System K181975|Oxoid Limited (Part of Thermo Fisher Scientific)|Philip Brame|Wade Road||Basingstoke||GB|RG24 8PW|RG24 8PW|07/24/2018|09/27/2018|SESE|MI|JTN|Summary|MI||Traditional|N||Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 K181980|Alphatec Spine, Inc.|Jeremy Markovich|5818 El Camino Real||Carlsbad|CA|US|92008|92008|07/25/2018|09/25/2018|SESE|OR|NKB|Summary|OR||Traditional|N||OsseoScrew System K181991|NxStage Medical, Inc|Christina Marabella|350 Merrimack Street||Lawrence|MA|US|01843|01843|07/26/2018|09/26/2018|SESE|GU|FKP|Summary|GU||Traditional|N||NxStage Connected Health System K181995|Chiral Surgical|Andy Choi|17310 Red Hill Ave, STE 335||Irvine|CA|US|92614|92614|07/26/2018|09/20/2018|SESE|OR|NKB|Summary|OR||Traditional|N||Chiral Surgical Pedicle Screw System K181999|Integra Lifesciences Corporation|Blesson Abraham|11101 Metric Blvd.||Austin|TX|US|78758|78758|07/26/2018|10/12/2018|SESE|OR|PHX|Summary|OR||Traditional|N||Integra TITAN Reverse Shoulder System K182015|CarboFix Orthopedics Ltd.|Yael Rubin|11 Ha'hoshlim St.||Herzeliya||IL|4672411|4672411|07/27/2018|10/11/2018|SESE|OR|HRS|Summary|OR||Traditional|N||Piccolo Composite® Plate System K182018|Shenzhen Kingyield Technology Co., Ltd.|Dacheng Gong|Section C2, Fuhai Industrial Zone, Fuyong Town,|Baoan District|Shenzhen||CN|518000|518000|07/27/2018|10/06/2018|SESE|CV|DXN|Summary|CV||Special|N||Bluetooth blood pressure monitor K182039|Arthrex Inc.|Courtney Smith|1370 Creekside Boulevard||Naples|FL|US|34108-1945|34108-1945|07/30/2018|09/28/2018|SESE|OR|PHX|Summary|OR||Traditional|N||Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay K182043|Hebei Titans Hongsen Medical Technology Co., LTD.|ShaoZhang Nan|Eastern Industrial Zone||Nangong||CN|051800|051800|07/30/2018|09/21/2018|SESE|HO|LYZ|Summary|HO||Traditional|N||Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) K182050|Siemens Medical Solutions USA, Inc.|Martin Rajchel|40 Liberty Boulevard, Mail Code 65-1A||Malvern|PA|US|19355|19355|07/31/2018|10/03/2018|SESE|RA|IYE|Summary|RA||Traditional|N||Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch K182051|FUJIFILM Corporation|Randy Vader|798 Miyanodai Kaisei-Machi||Ashigarakami-Gun||JP|258-8538|258-8538|07/31/2018|10/02/2018|SESE|GU|FDT|Summary|GU||Special|N||FUJIFILM Duodenoscope Model K182053|Alesi Surgical Ltd.|David Broderick|Cardiff MediCentre, HeathPark||Cardiff||GB|CF14 4UJ|CF14 4UJ|07/31/2018|09/07/2018|SESE|HO|PQM|Summary|SU||Special|N||Ultravision™ Visual Field Clearing System K182055|U&i Corporation|Kwang-Eun Song|20, Sandan-ro 76beon-gil(Rd)||Uijeongbu-si||KR|11781|11781|07/31/2018|09/10/2018|SESE|OR|KWQ|Summary|OR||Traditional|N||SECULOK™ ACP System K182059|GBS Commonwealth Co., Ltd.|Jimmy Kim|B-1007-1, Woolim Lion's Valley, 168, Gasan digital 1-ro||Geumcheon-gu||KR|08507|08507|07/31/2018|10/04/2018|SESE|OR|NKB|Summary|OR||Traditional|N||Prase MIS Spinal System K182070|BioHorizons Implant Systems, Inc.|Michael Davis|2300 Riverchase Center||Birmingham|AL|US|35244|35244|08/01/2018|10/10/2018|SESE|DE|DZE|Summary|DE||Special|N||BioHorizons Tapered IM Implants K182079|MEDTEC Inc. dba CIVCO Medical Solutions|Alena Newgren|1401 8th Street SE||Orange City|IA|US|51041-3020|51041-3020|08/02/2018|09/07/2018|SESE|RA|IYE|Summary|RA||Traditional|Y||Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask K182080|Xodus Medical, Inc.|Paul Lloyd|702 Prominence Drive||New Kensington|PA|US|15068|15068|08/02/2018|09/19/2018|SESE|SU|GCJ|Summary|GU||Traditional|N||Scope Antifogging System K182112|Infinite Biomedical Technologies, LLC|Rahul Kaliki|8 Market Place, Suite 500||Baltimore|MD|US|21202|21202|08/06/2018|10/05/2018|SESE|NE|GXY|Summary|NE||Traditional|N||Sense System with IBT Electrodes K182115|Ping An Medical Products Co., Ltd.|Fu Dong Zhang|Zhe Ji road, High-tech Industrial Zone of|Hukou County|Jiu Jiang||CN|332000|332000|08/06/2018|10/03/2018|SESE|HO|LYZ|Summary|HO||Traditional|N||Vinyl Patient Examination Gloves K182117|Jiangxi Zhonghong Pulin Medical Products Co., Ltd|Joe Zhang|Yinsha Wan Industrial Park, High-tech Industrial Zone of|Hukou County|Jiu Jiang||CN|332000|332000|08/06/2018|10/06/2018|SESE|HO|LYZ|Summary|HO||Traditional|N||Vinyl Patient Examination Gloves K182122|Coloplast Corp|Cori Ragan|1601 West River Road North||Minneapolis|MN|US|55411|55411|08/06/2018|10/04/2018|SESE|GU|EYB|Summary|GU||Traditional|N||Ureteric Catheters K182129|Siemens Medical Solutions USA, Inc.|Cordell L. Fields|65 Valley Stream Parkway 65-1A||Malvern|PA|US|19355|19355|08/06/2018|10/12/2018|SESE|RA|LNH|Summary|RA||Traditional|N||MAGNETOM Sola K182138|Eleckta Limited|Andrew Hedges|Linac House, Fleming Way||Crawley||GB|rh10 9rr|rh10 9rr|08/07/2018|09/05/2018|SESE|RA|IYE|Summary|RA||Traditional|N||Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD K182144|Promepla Sam|Alexandre Bareille|9 Avenue Albert II||Monaco||MC|98000|98000|08/08/2018|09/07/2018|SESE|GU|KNY|Summary|GU||Special|N||Bi-Flex Evo K182147|Analogic Corporation|Karen Provencher|8 Centennial Drive||Peabody|MA|US|01960|01960|08/08/2018|09/07/2018|SESE|RA|JAK|Summary|RA||Traditional|N||CTXX85 K182148|Paragon 28, Inc.|Eric Lintula|4B Inverness Ct. E, STE 280||Engelwood|CO|US|80112|80112|08/08/2018|09/07/2018|SESE|OR|HWC|Summary|OR||Special|N||SILVERBACK Gorilla Plating System K182151|CTL Medical Corporation|Andrea Wilcox|4550 Excel Parkway, Suite 300||Addison|TX|US|75001|75001|08/08/2018|10/11/2018|SESE|OR|OVE|Summary|OR||Traditional|N||MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate K182153|KONICA MINOLTA, INC.|Tsutomu Fukui|1 Sakura-machi||Hino-shi||JP|191-8511|191-8511|08/08/2018|09/06/2018|SESE|RA|IYO|Statement|RA||Special|N||Ultrasound System SONIMAGE HS1 K182157|Princeton BioMeditech Corp.|Kyung-ah Kim|4242 US Highway 1||Monmouth Junction|NJ|US|08852|08852|08/09/2018|09/18/2018|SESE|MI|PSZ|Statement|MI||Special|N||BioSign Flu A+B K182189|Qfix|Alexandra Low Smythe|440 Church Road||Avondale|PA|US|19311|19311|08/13/2018|10/04/2018|SESE|RA|IYE|Summary|RA||Special|N||Encompass SRS Headframe ; Encompass MR SRS Headframe K182196|Imediplus, Inc.|Moriah Hsieh|2F, 12, ShengYi Rd. Sec.2||Chupei City||TW|30261|30261|08/14/2018|09/11/2018|SESE|CV|DQD|Summary|CV||Traditional|Y||Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth K182206|Trident s.r.l|Giorgio Rizzo|Via Artigiani 4||Castenedolo||IT|25014|25014|08/15/2018|09/13/2018|SESE|RA|EHD|Summary|DE||Traditional|N||RiX70 DC K182208|Siemens Healthcare GmbH|Elango Alampalayam Rangappan|Siemensstr. 1||Forchheim||DE|91301|91301|08/15/2018|09/07/2018|SESE|RA|LLZ|Summary|RA||Abbreviated|Y||syngo.via View&GO (Version VA10A) K182213|QT Ultrasound LLC|Mark W. Lenox|3 Hamilton Landing, Suite 160||Novato|CA|US|94949|94949|08/15/2018|09/14/2018|SESE|RA|IYO|Summary|RA||Special|N||QT Ultrasound Breast Scanner - 1 K182214|DizzyDoctor Systems, LLC|Ian Purcell|7625 Mesa College Drive, Suite 200A||San Diego|CA|US|92111|92111|08/15/2018|09/14/2018|SESE|EN|GWN|Summary|NE||Traditional|Y||DizzyDoctor System 1.0.0 K182223|Canon Medical Systems USA|Paul Biggins|1385 Shimoishigami||Otawara-shi||JP|324-8550|324-8550|08/16/2018|09/14/2018|SESE|RA|JAK|Summary|RA||Traditional|N||Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A K182226|AirStrip Technologies, Inc.|Kirk Johnson|335 E. Sonterra Blvd., Suite #200||San Antonio|TX|US|78258|78258|08/16/2018|09/11/2018|SESE|CV|MWI|Summary|CV||Traditional|Y||AirStrip RPM InvisionHeart Adapter K182230|Vital Images, Inc.|Fei Li|5850 Opus Parkway, Suite 300||Minnetonka|MN|US|55343-4414|55343-4414|08/17/2018|09/07/2018|SESE|RA|LLZ|Summary|RA||Traditional|N||Multi Modality Viewer K182232|Vascular Solutions, Inc.|Iroquois Ledbeter|6401 Sycamore Ct N||Maple Grove|MN|US|55369|55369|08/17/2018|09/11/2018|SESE|CV|DXE|Summary|CV||Special|N||Octane Mechanical Thrombectomy System K182234|GE Medical Systems, LLC|Chris Paulik|3000 N. Grandview Blvd.||Waukesha|WI|US|53188|53188|08/17/2018|09/06/2018|SESE|RA|IZL|Summary|RA||Special|N||Optima XR240amx K182237|Shanghai United Imaging Healthcare Co., Ltd.|Shumei Wang|No. 2258 Chengbei Rd., Jiading Industrial District||Shanghai||CN|201807|201807|08/17/2018|10/12/2018|SESE|RA|KPS|Summary|RA||Traditional|N||uMI 550 PET/CT System K182243|Access Scientific, LLC|Martina Nguyen|3910 Sorrento Valley Boulevard, Suite 200||San Diego|CA|US|92121|92121|08/20/2018|09/18/2018|SESE|CV|DYB|Summary|CV||Special|N||The CVC WAND Safety Introducer with Valved Peelable Sheath K182244|Applied Medical Resources Corp.|Andrew Nguyen|22872 Avenida Empresa||Rancho Santa Margarita|CA|US|92688|92688|08/20/2018|10/11/2018|SESE|SU|GEI|Summary|SU||Special|N||Voyant Electrosurgical Generator K182247|VizionFocus, Inc.|Angus Shih|No.66, Youyi Rd.||Zhunan Township||TW|350|350|08/20/2018|10/12/2018|SESE|OP|LPL|Summary|OP||Traditional|N||ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) K182258|United States Endoscopy Group, Inc.|Carroll L. Martin|5976 Heisley Road||Mentor|OH|US|44060|44060|08/21/2018|09/21/2018|SESE|GU|FEQ|Statement|GU||Special|N||AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm K182260|Heraeus Medical GmbH|Ute Greiner|Philipp-Reis-Str. 8-13||Wehrheim||DE|61273|61273|08/21/2018|09/17/2018|SESE|OR|LOD|Summary|OR||Special|N||PALACOS MV K182263|Natus Medical Incorporated|Brian R. Ackley|1183 Quarry Lane, Suite A||Pleasanton|CA|US|94566|94566|08/21/2018|09/07/2018|SESE|OP|HKI|Summary|OP||Special|N||RetCam 3 ; RetCam Shuttle ; RetCam Portable K182275|Boston Scientific Corporation|Andrew Akers|100 Boston Scientific Way||Marlborough|MA|US|01752|01752|08/22/2018|09/13/2018|SESE|GU|OCX|Summary|GU||Special|N||Seal Single Use Biopsy Valve K182286|OSANG Healthcare Co., Ltd.|Jin Ho An|132, Anyangcheondong-Ro, Dongan-Gu||Anyang||KR|14040|14040|08/23/2018|09/19/2018|SESE|CH|NBW|Summary|CH||Special|N||Oh'Care Lite Smart Blood Glucose Monitoring System K182289|Shenzhen Baoan Medical Supplies Co., Ltd|Mingan Mu|No.6, Shenkeng Road, Shenkeng Industrial Zone Liuyue|Community, Henggang|Shenzhen||CN|518173|518173|08/23/2018|10/10/2018|SESE|CV|DXT|Summary|CV||Special|N||Sterile High-pressure Angiographic Syringes for Single-use K182290|Merge Healthcare Incorporated|Tracey Fox|900 Walnut Ridge Drive||Hartland|WI|US|53209|53209|08/23/2018|09/25/2018|SESE|RA|LLZ|Summary|RA||Traditional|N||IBM iConnect Access K182310|Volpara Health Technologies Limited|Ralph Highnam|Level 7, 44 Victoria Street, Wellington Central||Wellington||NZ|6011|6011|08/24/2018|09/21/2018|SESE|RA|LLZ|Summary|RA||Special|N||Volpara Imaging Software K182315|Boston Scientific Corporation|Andrea Dance|3 Scimed Place||Maple Grove|MN|US|55311|55311|08/27/2018|09/26/2018|SESE|CV|DQX|Summary|CV||Special|N||Magic Torque DLVR Guidewire K182317|OEHM UND REHBEIN GMBH|Markus Brueggmann|Neptunallee 7 C||Rostock||DE|18057|18057|08/27/2018|09/24/2018|SESE|RA|IZL|Summary|RA||Traditional|N||AMADEO M-DR mini, AMADEO M-AX mini K182325|Inmode MD Ltd.|Amit Goren|Tabor Building, Shaar Yokneam||Yoqneam Illit||IL|2069200|2069200|08/27/2018|09/26/2018|SESE|SU|GEI|Summary|SU||Special|N||InMode RF System K182335|Mentor Worldwide LLC|Martin Sprunck|33 Technology Drive||Irvine|CA|US|92618|92618|08/28/2018|09/25/2018|SESE|SU|LCJ|Summary|||Special|N||CPX 4 Breast Tissue Expander with Smooth Surface K182337|Balt USA, LLC|Nancy Xu|29 Parker||Irvine|CA|US|92618|92618|08/28/2018|10/04/2018|SESE|NE|MOF|Summary|CV||Traditional|Y||HYBRID Guidewire K182340|NICO Corporation|Sean Spence|250 East 96th Street, Suite 125||Indianapolis|IN|US|46240|46240|08/28/2018|09/20/2018|SESE|SU|GEI|Summary|SU||Special|N||NICO Myriad K182345|Spineology Inc|Karen Roche|7800 Third Street N., Suite 600||St. Paul|MN|US|55128|55128|08/28/2018|09/21/2018|SESE|OR|OLO|Summary|NE||Special|N||Spineology Navigation Instruments K182357|Hardy Diagnostics|Anna Klavins|1430 West McCoy Lane||Santa Maria|CA|US|93455|93455|08/30/2018|09/26/2018|SESE|MI|JTN|Statement|MI||Traditional|N||HardyDisk AST Eravacycline 20µg (ERV20) K182370|RootLoc Co., Ltd.|Jungsun Ha|#1206, 1210, 68, Digital-ro 9-gil, Geumcheon-gu||Seoul||KR|08512|08512|08/31/2018|09/27/2018|SESE|OR|JWH|Summary|OR||Special|N||Acculoc Total Knee System K182376|Topcon Medical Systems, Inc.|James Lorkowski|111 Bauer Drive||Oakland|NJ|US|07436|07436|08/31/2018|09/28/2018|SESE|OP|NFJ|Summary|RA||Special|N||Harmony K182377|CarboFix Orthopedics Ltd.|Hila Wachsler-Avrahami|11 Ha'hoshlim St.||Herzeliya||IL|4672411|4672411|08/31/2018|09/27/2018|SESE|OR|NKB|Summary|OR||Special|N||CarboClear® Pedicle Screw System K182402|In2Bones USA, LLC|Christine Scifert|6060 Poplar Ave, Suite 380||Memphis|TN|US|38119|38119|09/04/2018|09/27/2018|SESE|OR|HRS|Summary|OR||Special|N||CoLink View Plating System K182415|Canon Medical Systems Corporation|Paul Biggins|1385 Shimoishigami||Otawara||JP|324-8550|324-8550|09/04/2018|09/28/2018|SESE|RA|OWB|Summary|RA||Traditional|N||Alphenix, INFX-8000F/B, V8.0 K182423|Shenzhen New Industries Biomedical Engineering Co., Ltd|Jie Rao|No.16, Jinhui Road, Pingshan New District||Shenzhen||CN|518122|518122|09/06/2018|10/04/2018|SESE|CH|CEC|Summary|CH||Traditional|N||MAGLUMI 2000 FT4 K182436|Medtronic Sofamor Danek USA, Inc.|Ankit K. Shah|1800 Pyramid Place||Memphis|TN|US|38132|38132|09/07/2018|10/04/2018|SESE|NE|HBE|Summary|NE||Special|N||POWEREASE System K182490|EMS Electro Medical Systems SA|Sonia Callegaro|Ch de la Vuarpilliere||Nyon||CH|1260|1260|09/11/2018|10/09/2018|SESE|GU|FEO|Summary|GU||Special|N||Swiss LithoClast Trilogy K182492|Skeletal Dynamics, LLC|Ana M. Escagedo|7300 North Kendall Drive, Suite 400||Miami|FL|US|33156|33156|09/11/2018|10/10/2018|SESE|OR|HRS|Summary|OR||Special|N||Geminus Volar Distal Radius Plate System K182504|GE Healthcare Coils (USA Instruments, Inc.)|Veronica A. Meridith|1515 Danner Drive||Aurora|OH|US|44202|44202|09/12/2018|10/12/2018|SESE|RA|MOS|Summary|RA||Traditional|N||3.0T Air MP M, 3.0T Air MP L K182522|Penumbra, Inc.|Micaela Victoria|One Penumbra Place||Alameda|CA|US|94502|94502|09/13/2018|10/12/2018|SESE|NE|NRY|Summary|CV||Special|N||Penumbra System (Modified 110 Aspiration Tubing) K182531|Inari Medical|Eben Gordon|9272 Jeronimo Road|Suite 124|Irvine|CA|US|92618|92618|09/14/2018|10/10/2018|SESE|CV|DXE|Summary|CV||Special|N||ClotTriever Thrombectomy System K182533|Pixxgen Corporation|John Ross|5F, Smart Bay, 123, Beolmal-ro, Dongan-gu||Anyang-si||KR|14056|14056|09/14/2018|10/04/2018|SESE|RA|MQB|Summary|RA||Traditional|N||PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels K182536|Exactech, Inc.|Zach Sharrah|2320 NW 66th Court||Gainesville|FL|US|32653|32653|09/14/2018|10/12/2018|SESE|OR|PHX|Summary|OR||Special|N||Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap K182539|JVC Kenwood Corporation|Masafumi Yugami|3-12, Moriya-cho, Kanagawa-ku||Yokohama||JP|221-0022|221-0022|09/14/2018|10/03/2018|SESE|RA|PGY|Summary|RA||Traditional|N||2MP Color LCD Monitor CL-R211 K182826|Sybron Dental Specialties|Mey Saied|1717 W. Collins Ave.||Orange|CA|US|92687|92687|10/05/2018|10/11/2018|SESE|DE|NXC|Summary|DE||Traditional|Y||Ormco Spark Aligner System