| K163116 — Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 | Philips Medical Systems Nederland B.V. Jan 6, 2017 |
| K163444 — Spectre guidewire | Vascular Solutions, Inc. Jan 6, 2017 |
| K162931 — Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 | Philips Medical Systems Nederland B.V. Jan 6, 2017 |
| K161504 — Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray | Cook Incorporated Jan 6, 2017 |
| K162490 — Disc-FX System | Elliquence, LLC Jan 6, 2017 |
| K163490 — StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation Jan 6, 2017 |
| K163013 — Quantib Brain 1.2 | Quantib B.V. Jan 6, 2017 |
| K161463 — SureClip(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. Jan 6, 2017 |
| K163492 — Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear | United States Endoscopy Group, Inc. Jan 6, 2017 |
| K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | DiaSorin, Inc. Jan 6, 2017 |
| K162887 — PrismaSATE | Baxter Healthcare Corporation Jan 6, 2017 |
| K162086 — MultiStim ECO | PAJUNK GmbH Medizintechnologie Jan 6, 2017 |
| K162946 — 8ch Knee-Foot SPEEDER | Quality Electrodynamics, LLC Jan 6, 2017 |
| K163456 — DuraGen Secure Dural Regeneration Matrix | Integra LifeSciences Corporation Jan 6, 2017 |
| K162253 — Trapper Exchange Device | Creganna Medical Aslo Business AS Cregganna Tactx Medical Jan 6, 2017 |
| K162181 — Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. Jan 6, 2017 |
| K163457 — NeuraGen 3D Nerve Guide Matrix | Integra LifeSciences Corporation Jan 6, 2017 |
| K161036 — Hospira Extension Set, Hospira Primary Set | Hospira, Inc. Jan 6, 2017 |
| K162763 — Vevazz LED Heat Lamp | Vevazz, LLC Jan 5, 2017 |
| K162561 — Turbo-Power (2.0mm) Laser Atherectomy Catheters | Spectranetics, Inc. Jan 5, 2017 |
| K160469 — AGNES | Gowoonsesang Cosmetics Co., Ltd. Jan 5, 2017 |
| K163454 — ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm | Ethicon Endo-Surgery, LLC Jan 5, 2017 |
| K161202 — C2 Cryoballoon Ablation System | C2 Therapeutics, Inc. Jan 5, 2017 |
| K161637 — Poseidon OCT Spinal Fixation System | Medyssey USA, Inc. Jan 5, 2017 |
| K161641 — LOSPA IS ACP System | Corentec Co., Ltd. Jan 5, 2017 |
| K163253 — Arterys Cardio DL | Arterys, Inc. Jan 5, 2017 |
| K162146 — Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) | Brightway Holdings Sdn. Bhd. Jan 5, 2017 |
| K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC Jan 5, 2017 |
| K162563 — YOGA Microcatheter | Codman & Shurtleff, Inc. Jan 5, 2017 |
| K162064 — CrossBay IVF Embryo Transfer Catheter Set | Crossbay Medical, Inc. Jan 5, 2017 |
| K160536 — Chaorum Implant System | Medimecca Co., Ltd. Jan 5, 2017 |
| K163114 — Sapphire II PRO | Orbusneich Medical, Inc. Jan 5, 2017 |
| K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set | DiaSorin, Inc. Jan 5, 2017 |
| K161536 — EasyOne Air Spirometer | Ndd Medizintechnik AG Jan 5, 2017 |
| K153184 — Caremed Reusable & Disposable SPO2 Sensors | Shenzhen Caremed Medical Technology Co., Ltd. Jan 4, 2017 |
| K161270 — CephSimulation | Anatomage, Inc. Jan 4, 2017 |
| K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | DiaSorin, Inc. Jan 4, 2017 |
| K162770 — Relign System | Relign Corporation Jan 4, 2017 |
| K163429 — B6 | Beijing East Whale Imaging Technology Co., Ltd. Jan 4, 2017 |
| K162223 — Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | Supervision Optimax Sdn Bhd Jan 4, 2017 |
| K163396 — ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. Jan 4, 2017 |
| K162234 — Truscope Ultra Patient Monitor | Guangdong Biolight Meditech Co., Ltd. Jan 4, 2017 |
| K163410 — DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Ltd. Jan 4, 2017 |
| K163424 — AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON | United State Endoscopy Group, Inc. Jan 4, 2017 |
| K163421 — syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. Jan 3, 2017 |
| K163408 — Isolator Multifunctional Linear Pen | AtriCure, Inc. Jan 3, 2017 |
| K163427 — X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. Jan 3, 2017 |
| K162704 — Axium Prime Detachable Coil System | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jan 3, 2017 |
| K162423 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Haemonetics Corporation Jan 3, 2017 |
| K162084 — MOTO Partial Knee System | Medacta International S.A. Jan 3, 2017 |