| K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | Inova Diagnostics, Inc. Feb 3, 2017 |
| K162439 — AxSOS 3 Ti; Stryker Plating System | Stryker GmbH Feb 3, 2017 |
| K162106 — Micro-current Wrinkle Reduction Facial service, model EP-400 | Li-Tek Electronic Technology Corporation Feb 3, 2017 |
| K162388 — CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) | Curaseal, Inc. Feb 3, 2017 |
| K162683 — RehaStim 2 | Hasomed GmbH Feb 3, 2017 |
| K161901 — TrapLiner catheter | Vascular Solutions, Inc. Feb 3, 2017 |
| K163155 — MTM Clear Aligner | Dentsply Sirona Feb 3, 2017 |
| K163511 — NovaGuard SA Pro Safety System | West Pharmaceutical Services, Inc. Feb 2, 2017 |
| K161103 — US SA Implant System | Osstem Implant Co., Ltd. Feb 2, 2017 |
| K163268 — FlexCath Select Steerable Shealth and Dilator | Medtronic Cryocath, LP Feb 2, 2017 |
| K163123 — Q-Switched Nd:YAG Laser Therapy Systems | Beijing Sincoheren Science And Technology Development Co. Feb 2, 2017 |
| K161552 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe | Becton, Dickinson And Company Feb 2, 2017 |
| K170019 — Aquilion Lightning, TSX-036A/1, V8.4 | Toshibamedical Systems Corporation Feb 2, 2017 |
| K170061 — ProMIS Fixation System | Premia Spine, Ltd. Feb 2, 2017 |
| K160835 — Titan 3W | Tzora Active Systems , Ltd. Feb 2, 2017 |
| K163428 — HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity Feb 2, 2017 |
| K162726 — Exactech® Equinoxe® Preserve Stem | Exactech, Inc. Feb 1, 2017 |
| K162454 — PicoWay Laser System | Syneron Candela Corporation Feb 1, 2017 |
| K162958 — MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge | Medtronic, Inc. Feb 1, 2017 |
| K162624 — Pre-Formed Penile Silicone Block | International Medical Devices, Inc. Feb 1, 2017 |
| K163095 — Lyme B. burgdorferi (IgG) MarStripe Test | Trinity Biotech Feb 1, 2017 |
| K163083 — VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) | bioMerieux, Inc. Feb 1, 2017 |
| K161587 — Memodyn Staple | Austin & Associates, Inc./Telos Medical Equipment Feb 1, 2017 |
| K162144 — iHealth Wireless Blood Pressure Monitor | Andon Health Co, Ltd. Feb 1, 2017 |
| K161360 — U2 Total Knee System, PSA Tibial Insert | United Orthopedic Corporation Feb 1, 2017 |
| K162467 — Twin-Pass Torque | Vascular Solutions, Inc. Feb 1, 2017 |
| K161279 — Life Spine Metatarsal Hemi Implant | Life Spine, Inc. Feb 1, 2017 |
| K163440 — Stealth Staple System | First Ray, LLC Feb 1, 2017 |
| K160471 — Medline Non-Surgical Isolation Gown- | Medline Industries, Inc. Jan 31, 2017 |
| K161949 — OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. Jan 31, 2017 |
| K163210 — Philips CombiDiagnost R90 | Philips Medical Systems Dmc GmbH Jan 31, 2017 |
| K163170 — Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 | Capillus, LLC Jan 31, 2017 |
| K161158 — IDS-iSYS Intact PTHN | Immunodiagnostic Systems , Ltd. Jan 31, 2017 |
| K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | Datascope Corp. Jan 31, 2017 |
| K163122 — NobelClinician, DTX Studio implant | Nobel Biocare AB Jan 31, 2017 |
| K162381 — HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs | Healthy Glove Co., Ltd. Jan 31, 2017 |
| K162055 — Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. Jan 31, 2017 |
| K162034 — OBS Electrosurgical Generator (Model: OBS-350A) | Baisheng Medical Co., Ltd. Jan 30, 2017 |
| K162879 — Elite Expandable Interbody Fusion Device | Spineology, Inc. Jan 30, 2017 |
| K163004 — Radifocus Glidewire Advantage Track | Ashitaka Factory Of Terumo Coporation Jan 30, 2017 |
| K162390 — ET Hybrid Abutment | Hiossen, Inc. Jan 30, 2017 |
| K162098 — LED Phototherapy Device | Li-Tek Electronic Technology Corporation Jan 30, 2017 |
| K163058 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific Jan 30, 2017 |
| K162842 — ASAHI PTCA Guide Wire ASAHI SUOH 03 | Asahi Intecc Co., Ltd. Jan 27, 2017 |
| K163324 — nordicBrainEx | Nordicneurolab AS Jan 27, 2017 |
| K163689 — 3M Clear Tray Aligner | 3M Unitek Corporation Jan 27, 2017 |
| K161967 — FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm | Callisyn Biomedical, Inc. Jan 27, 2017 |
| K162088 — Ecomed Disposable Angiographic Syringes | Ecomed Solutions, LLC Jan 27, 2017 |
| K162631 — VERIFY STEAM Integrating Indicator - Short | STERIS Corporation Jan 27, 2017 |
| K163280 — RP Lite 760R | Mego Afek AC , Ltd. Jan 27, 2017 |