| K182360 — Teleport Microcatheter | Orbusneich Medical Trading, Inc. Nov 9, 2018 |
| K182481 — HEM-6410T-ZM Wrist Blood Pressure Monitor | Omron Healthcare, Inc. Nov 9, 2018 |
| K182565 — AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. Nov 9, 2018 |
| K182083 — Catalys Precision Laser System | Amo Manufacturing USA, LLC Nov 9, 2018 |
| K182484 — VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. Nov 9, 2018 |
| K182530 — BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. Nov 9, 2018 |
| K180732 — MiroCam Capsule Endoscope System | Intromedic Co., Ltd. Nov 8, 2018 |
| K181590 — Neurostructures Cavetto® [MAX] Cervical Cage System | Neurostructures, Inc. Nov 8, 2018 |
| K182166 — Wrist Blood Pressure Monitor Model BP4350 | Omron Healthcare, Inc. Nov 8, 2018 |
| K182329 — SureCure Orthodontic Aligner System | Digital Orthodontic Care Nov 8, 2018 |
| K180047 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa Nov 8, 2018 |
| K181684 — VAMP Plus Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC Nov 8, 2018 |
| K182838 — Geistlich Derma-Gide | Geistlich Pharma AG Nov 8, 2018 |
| K182472 — Cepheid Xpert GBS LB Control Panel | Microbiologics, Inc. Nov 8, 2018 |
| K180631 — Silk Voice | Sofregen Medical, Inc. Nov 8, 2018 |
| K181918 — CardioInsight Cardiac Mapping System | Medtronic, Inc. Nov 8, 2018 |
| K182462 — Exactech Alteon Highly Polished Femoral Stem | Exactech, Inc. Nov 8, 2018 |
| K173917 — neoClose PDS | Neosurgical, Ltd. Nov 8, 2018 |
| K182030 — Faros Mobile | Bittium Biosignals , Ltd. Nov 8, 2018 |
| K180949 — Steribite | Rjr Surgical, Inc. Nov 8, 2018 |
| K182220 — Curbell branded Patient Monitoring Cables | Curbell Medical Products, Inc. Nov 7, 2018 |
| K172999 — uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. Nov 7, 2018 |
| K180683 — Certa Dose Pediatric Midazolam 5mg/mL IM Syringe | Certa Dose, Inc. Nov 7, 2018 |
| K173001 — uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. Nov 7, 2018 |
| K182162 — OptiBond eXTRa Universal | Kerr Corporation Nov 7, 2018 |
| K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control Pack | Diasorin Molecular, LLC Nov 7, 2018 |
| K180381 — Powder Free Vinyl Patient Examination Gloves | Shanxi Hongjin Plastic Technology Co., Ltd. Nov 7, 2018 |
| K181934 — Vivid T8, Vivid T9 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Nov 6, 2018 |
| K181939 — icobrain | Icometrix NV Nov 6, 2018 |
| DEN170049 — Innovo | Bio-Medical Research, Ltd. Nov 6, 2018 |
| K181846 — ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System | Globus Medical, Inc. Nov 6, 2018 |
| K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments, LLC Nov 6, 2018 |
| K173916 — Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. Nov 6, 2018 |
| K182451 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC Nov 6, 2018 |
| K182216 — Merit Syringe | Merit Medical Systems, Inc. Nov 6, 2018 |
| K182442 — MiniGuard Arterial Safety Valve | Quest Medical, Inc. Nov 6, 2018 |
| K180838 — SaliPen | Saliwell , Ltd. Nov 6, 2018 |
| K181757 — Günther Tulip® Vena Cava Filter Retrieval Set | Cook Incorporated Nov 6, 2018 |
| K182279 — Merit Syringe | Merit Medical Systems, Inc. Nov 6, 2018 |
| K172668 — W Zirconia Implants | Tav Medical , Ltd. Nov 6, 2018 |
| K182444 — ERBEFLO Olympus Scope Port Connector | Erbe USA, Inc. Nov 6, 2018 |
| K173857 — Elecsys Tacrolimus | Roche Diagnostics Nov 6, 2018 |
| K181613 — MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D | Siemens Medical Solutions USA, Inc. Nov 6, 2018 |
| K182425 — Universal Mesh - Sterile | Stryker Leibinger GmbH & Co KG Nov 6, 2018 |
| K180469 — ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | Coloplast Corp. Nov 6, 2018 |
| K182559 — PREMIER Platinum HpSA PLUS | Meridian Bioscience, Inc. Nov 5, 2018 |
| K181781 — DynaClipTM Bone Staple | MedShape, Inc. Nov 5, 2018 |
| K181288 — Athelas One | Athelas, Inc. Nov 5, 2018 |
| K182160 — 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM | Stryker Nov 5, 2018 |
| K181258 — ConnectedOR Hub with Device and Voice Control | Stryker Nov 5, 2018 |