| K162723 — TransFix/EDTA Vacuum Blood Collection Tubes | Caltag Medsystems, Ltd. Jun 22, 2017 |
| K170016 — Biodesign Fistula Plug | Cook Biotech Incorporated Jun 21, 2017 |
| K170551 — ImPACT Quick Test | Impact Applications, Inc. Jun 21, 2017 |
| K163049 — GOLNIT Non-Absorbable PTFE Surgical Suture | Antarma Dba Golnit Sutures Jun 21, 2017 |
| K170638 — Retina Workplace | Carl Zeiss Meditec, AG Jun 21, 2017 |
| K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | Maine Standards Company, LLC Jun 21, 2017 |
| K163195 — PRIMUS | Carl Zeiss Suzhou Co., Ltd. Jun 21, 2017 |
| K171485 — BSD4343R Digital Flat Panel X-ray Detector | Bontech, Inc. Jun 21, 2017 |
| K161808 — Solution Set with 1.2 Micron Air Eliminating Filter | Baxter Healthcare Corporation Jun 21, 2017 |
| K170714 — Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Jun 21, 2017 |
| DEN160040 — Embosphere Microspheres | Biosphere Medical, S.A. Jun 21, 2017 |
| K163345 — TVC Imaging System, TVC Catheter | Infraredx, Inc. Jun 21, 2017 |
| K170755 — DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc. Jun 21, 2017 |
| K163104 — Terrace Anterior Cervical Plate System | Corelink, LLC Jun 21, 2017 |
| K162737 — VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) | bioMerieux, Inc. Jun 21, 2017 |
| K170418 — Stryker SonicPin System | Stryker Trauma GmbH Jun 20, 2017 |
| K163593 — Additive Orthopaedics Bunion System | Additive Orthopaedics, LLC Jun 20, 2017 |
| K170039 — STERRAD VELOCITY Biological Indictator and Reader | Advanced Sterilization Products (Asp) Jun 20, 2017 |
| K170571 — Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw | Tyber Medical, LLC Jun 20, 2017 |
| K162942 — Corin MetaFix Hip Stem | Corin U.S.A. Limited Jun 20, 2017 |
| K162515 — COSMED K5 Wearable Metabolic Technology | Cosmed Srl Jun 20, 2017 |
| K170918 — Compex Sport Elite | Djo, LLC Jun 20, 2017 |
| K163494 — Summit Spine Channel Cervical Interbody Fusion System | Summit Spine Jun 20, 2017 |
| K163447 — Premium Plus Disposable Barrier Sleeve | Premium Plus International Limited Jun 20, 2017 |
| K163029 — Hydris Oral Rinse | Biopharm Consult, LLC Jun 19, 2017 |
| K170693 — Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. Jun 19, 2017 |
| K163506 — Coalesce (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System | Vertera, Inc. Jun 19, 2017 |
| K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. Jun 19, 2017 |
| K170903 — Compex Wireless USA | Djo, LLC Jun 19, 2017 |
| K170893 — Materialise Glenoid Positioning System | Materialise NV Jun 19, 2017 |
| K170669 — Insulia Diabetes Management Companion | Voluntis Sa. Jun 19, 2017 |
| K162588 — Möller Medical Biopsy Needles and Systems | Moller Medical GmbH Jun 19, 2017 |
| K162886 — DEKA MOTUS AX | El.En Electronic Engineering Spa Jun 19, 2017 |
| K162641 — Smith & Nephew, Inc. R3 Constrained Liner | Smith & Nephew, Inc. Jun 19, 2017 |
| K171481 — MagVita TMS Therapy System | Tonica Elektronik A/S Jun 16, 2017 |
| K170066 — Green16/Green18 (Model: PHT-65LHS) | VATECH Co., Ltd. Jun 16, 2017 |
| K170843 — Alians Fragment Specific | Newclip Technics Jun 16, 2017 |
| K162674 — BioPro Foot Plating Systems | Biopro, Inc. Jun 16, 2017 |
| K163676 — Silhouette InstaLift | Silhouette Lift, Inc. Jun 16, 2017 |
| K162659 — Diode Laser Hair Removal System | Shandong Huamei Technology Co., Ltd. Jun 16, 2017 |
| K161582 — DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. Jun 16, 2017 |
| K170909 — Infinix INFX-8000V, V6.40 | Toshiba Medical Systems Coroporation Jun 16, 2017 |
| K162215 — Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae | Sorin Group Italia S.R.L. Jun 16, 2017 |
| K170191 — SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System | Medtronic Vascular, Inc. Jun 16, 2017 |
| K170474 — Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter | Innovative Health, LLC Jun 16, 2017 |
| K171538 — Cure Lumbar Plate System | Meditech Spine, LLC Jun 16, 2017 |
| K171223 — Quantum TTC Biliary Balloon Dilator | Wilson-Cook Medical, Inc. Jun 16, 2017 |
| K161533 — A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. Jun 16, 2017 |
| K170198 — Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) | Cardinal Health, Inc. Jun 15, 2017 |
| K162826 — Encore Neutral | Rymed Technologies, LLC Jun 15, 2017 |