| K180040 — NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter | Abbott Vascular Aug 24, 2018 |
| K173541 — EPINAUT | Imedicom Co., Ltd. Aug 24, 2018 |
| K180373 — CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical, LLC Aug 24, 2018 |
| K181009 — APTUS CMC-I Fusion Plate System | Medartis AG Aug 24, 2018 |
| K173771 — IOLMaster 700 | Carl Zeiss Meditec, AG Aug 24, 2018 |
| K181060 — Solitaire 2 and Solitaire Platinum Revascularization Device | Medtronic Neurovascular Aug 24, 2018 |
| K181035 — AOS Small Fragment Plating System Lite | Advanced Orthopaedic Solutions, Inc. (Aos) Aug 24, 2018 |
| K173978 — CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | Biosense Webster, Inc. Aug 24, 2018 |
| K181386 — NuVasive Brigade Lateral System | Nu Vasive, Incorporated Aug 24, 2018 |
| K172830 — Double Medical Femoral Nail System | Double Medical Technology, Inc. Aug 24, 2018 |
| K180179 — Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw | Orthofix, Inc. Aug 24, 2018 |
| K181609 — RadiForce GX560, GX560-AR | Eizo Corporation Aug 24, 2018 |
| K182057 — EasyMax BT Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. Aug 24, 2018 |
| K173673 — AcuSnare Polypectomy Snare | Wilson-Cook Medical, Inc. Aug 24, 2018 |
| K173890 — GMK Sphere - Kinematic Alignment | Medacta International S.A. Aug 23, 2018 |
| K180186 — Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation Aug 23, 2018 |
| K181333 — ADVIA Centaur Herpes-1 IgG | Biokit, S.A. Aug 23, 2018 |
| K181334 — ADVIA Centaur Herpes-2 IgG | Biokit, S.A. Aug 23, 2018 |
| DEN170090 — MATRx plus | Zephyr Sleep Technologies Aug 23, 2018 |
| K170050 — Z-CAD smile | Metoxit AG Aug 23, 2018 |
| K173784 — Smylic Invisible Clear Aligners | Smylio, Inc. Aug 23, 2018 |
| K180173 — Freespira | Palo Alto Health Sciences, Inc. Aug 23, 2018 |
| K181439 — SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation Aug 23, 2018 |
| K181635 — GMK Sphere CR Tibial Inserts | Medacta International S.A. Aug 23, 2018 |
| K173657 — Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter | Cook Incorporated Aug 23, 2018 |
| K173732 — Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. Aug 23, 2018 |
| K181974 — MyoSure XL Tissue Removal Device for Fluent | Hologic, Inc. Aug 23, 2018 |
| K180542 — NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech, Aug 22, 2018 |
| K181312 — GrandioSO x-tra | Voco GmbH Aug 22, 2018 |
| K173024 — Non-invasive blood pressure measurement systems | Joytech Healthcare Co. , Ltd. Aug 22, 2018 |
| K181954 — autoLog IQ Autotransfusion System | Medtronic Perfusion Systems Aug 22, 2018 |
| K173658 — Confidence Blood Glucose Monitoring System | Applied Biomedical, LLC Aug 21, 2018 |
| K181379 — H. PYLORI QUIK CHEK | Techlab, Inc. Aug 21, 2018 |
| K180698 — PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited Aug 21, 2018 |
| K181973 — Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. Aug 21, 2018 |
| K181435 — ATEC Cervical Spacer System | Alphatec Spine, Inc. Aug 21, 2018 |
| K181791 — SIMPLYSTRONG, SIMPLYEZEE | Genicon, Inc. Aug 21, 2018 |
| K181400 — H. PYLORI CHEK | Techlab, Inc. Aug 21, 2018 |
| K181013 — Fever Scout | VivaLNK, Inc. Aug 21, 2018 |
| K180957 — exGraft, exGraft Carbon ePTFE Vascular Grafts | Peca Labs Aug 21, 2018 |
| K173197 — Reusable NIBP Cuff | Orantech, Inc. Aug 21, 2018 |
| K181982 — MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. Aug 21, 2018 |
| K182004 — PENTAX Medical Endoscopic Ultrasound System | Pentax Of America, Inc. Aug 21, 2018 |
| K181968 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | Safecare Biotech (Hangzhou) Co., Ltd. Aug 20, 2018 |
| K181768 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. Aug 20, 2018 |
| K171377 — Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co. 1, LLC Aug 20, 2018 |
| K180850 — re.t.a Reuseable Tampon Applicator | Thinx, Inc. Aug 20, 2018 |
| K171890 — BEXCORE Breast Biopsy System, Biopsy Needle | Medical Park Co., Ltd. Aug 20, 2018 |
| K170824 — BD Vacutainer Eclipse Signal Blood Collection Needle | Becton, Dickinson And Company Aug 20, 2018 |
| K180775 — Watch-PAT300 | Itamar Medical , Ltd. Aug 17, 2018 |