| PeriFLEX (K162611) | Spiration, Inc. | 2017-02-09 |
| syngo.CT Extended Functionality (K163341) | Siemens Medical Solutions USA, Inc. | 2017-02-09 |
| Porcine Anorganic Bone Mineral in Delivery Applicator (K162158) | Collagen Matrix, Inc. | 2017-02-09 |
| RASL Repair Kit (K161334) | Radicle Orthopaedics, Inc. | 2017-02-09 |
| DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long (K163046) | DePuy Synthes | 2017-02-09 |
| cobas® CT/NG v2.0 Test (K163184) | Roche Molecular Systems, Inc. | 2017-02-09 |
| AcuNav Volume ICE Catheter (K163478) | Siemens Medical Solutions USA, Inc. | 2017-02-09 |
| Scopis Hybrid Navigation System EM (K161491) | Scopis GmbH | 2017-02-09 |
| Hubble I System (K163566) | Orbbo Surgical, LLC | 2017-02-09 |
| BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161810) | Becton Dickinson | 2017-02-09 |
| PIVO (K163508) | Velano Vascular | 2017-02-09 |
| APTUS® Coronoid 2.0 (K161861) | Medartis AG | 2017-02-09 |
| Pinnacle Radiation Therapy Planning System (K170086) | Philips Medical Systems (Cleveland), Inc. | 2017-02-09 |
| syngo. CT Single Source Dual Energy (twin beam) (K163289) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2017-02-09 |
| pixium 4343RCE (K170113) | Philips Medical Systems Dmc GmbH | 2017-02-09 |
| Arm-Type Fully Automatic Digital Blood Pressure Monitor (K161577) | Sejoy Electronics & Instruments Co., Ltd. | 2017-02-08 |
| Fully Automatic Electronic Blood Pressure Monitor (K162915) | Andon Health Co, Ltd. | 2017-02-08 |
| VIVIX-S 1417N (K163703) | Vieworks Co., Ltd. | 2017-02-08 |
| OptosAdvance 4.0 Software (K162039) | Optos Plc. | 2017-02-08 |
| FB-U Hemodialyzer (K160444) | Nipro Medical Corporation | 2017-02-08 |
| MyNeWT Negative Pressure Wound Therapy System (K161432) | Stortford Medical, LLC | 2017-02-08 |
| Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove (K162852) | Lucenxia Prescience AG | 2017-02-08 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K162491) | Hartalega Sdn Bhd | 2017-02-08 |
| Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (K162840) | Roche Diagnostics | 2017-02-08 |
| Transformair Indoor Air Purifier (K161468) | Transformair, LLC | 2017-02-08 |
| Handheld Diode Laser for Hair Removal (K163173) | Liaoning Sidey Optoelectronics Technologies Co., Ltd. | 2017-02-08 |
| Smart Pain Reliever, Model LT5019 (K162479) | Shenzhen Dongdixin Technology Co., Ltd. | 2017-02-08 |
| EndyGel (K161715) | Endymed Medical, Ltd. | 2017-02-07 |
| Fitmore® Hip Stem (K170072) | Zimmer GmbH | 2017-02-07 |
| PUREtrace™ (K153262) | Nemo Healthcare BV | 2017-02-07 |
| Proficient™ Posterior Cervical Spine System (K162639) | Spine Wave, Inc. | 2017-02-07 |
| Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent (K163169) | Cook Ireland, Ltd. | 2017-02-07 |
| Unicare System, Unicare Manipulator (K163214) | Clearpath Surgical, Inc. | 2017-02-07 |
| Fuselier Intraoral Nighttime Device (FIND) (K161980) | Fuselier Enterprises, LLC | 2017-02-07 |
| syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology (K163294) | Siemens Medical Solutions USA, Inc. | 2017-02-06 |
| Variola virus Real-Time PCR Assay (DEN160016) | Centers For Disease Control and Prevention (CDC) | 2017-02-06 |
| UC-CARE NaviGo Workstation (K160934) | UC-CARE , Ltd. | 2017-02-06 |
| 3M Protemp Cement Temporary Dental Cement (K170330) | 3M Company | 2017-02-06 |
| Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) (K162014) | Bluepoint Medical GmbH & Co. KG | 2017-02-06 |
| Altus Spine Cervical Plate System (K163061) | Altus Partners, LLC | 2017-02-06 |
| DCM Kyphoplasty System (K162283) | Dragon Crown Medical Co., Ltd. | 2017-02-06 |
| EndoWrist Suction Irrigator (K162973) | Intuitive Surgical, Inc. | 2017-02-06 |
| NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE (K162923) | Hartalega NGC Sdn. Bhd. | 2017-02-06 |
| SEEKER System (DEN150035) | Baebies, Inc. | 2017-02-03 |
| MTM Clear Aligner (K163155) | Dentsply Sirona | 2017-02-03 |
| PICC Maximal Barrier Nursing Kit (K163452) | Navilyst Medical, Inc. | 2017-02-03 |
| LenSx Laser System (K163551) | Alcon Laboratories, Inc. | 2017-02-03 |
| Micro-current Wrinkle Reduction Facial service, model EP-400 (K162106) | Li-Tek Electronic Technology Corporation | 2017-02-03 |
| ActiPatch(R) (K152432) | Bioelectronics Corporation | 2017-02-03 |
| Telemetry Transmitter (K161056) | Edan Instruments, Inc. | 2017-02-03 |
| CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) (K162388) | Curaseal, Inc. | 2017-02-03 |
| GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord (K162536) | Kerr Corporation | 2017-02-03 |
| NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit (K161258) | Inova Diagnostics, Inc. | 2017-02-03 |
| TrapLiner catheter (K161901) | Vascular Solutions, Inc. | 2017-02-03 |
| AxSOS 3 Ti; Stryker Plating System (K162439) | Stryker GmbH | 2017-02-03 |
| priti multidisc ZrO2 High Translucent (K161025) | Pritidenta GmbH | 2017-02-03 |
| RehaStim 2 (K162683) | Hasomed GmbH | 2017-02-03 |
| ProMIS™ Fixation System (K170061) | Premia Spine, Ltd. | 2017-02-02 |
| FlexCath Select Steerable Shealth and Dilator (K163268) | Medtronic Cryocath, LP | 2017-02-02 |
| Aquilion Lightning, TSX-036A/1, V8.4 (K170019) | Toshibamedical Systems Corporation | 2017-02-02 |
| Q-Switched Nd:YAG Laser Therapy Systems (K163123) | Beijing Sincoheren Science and Technology Development Co. | 2017-02-02 |
| 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe (K161552) | Becton, Dickinson and Company | 2017-02-02 |
| HA Minuteman G3-R MIS Fusion Plate (K163428) | Spinal Simplicity | 2017-02-02 |
| US SA Implant System (K161103) | Osstem Implant Co., Ltd. | 2017-02-02 |
| Titan 3W (K160835) | Tzora Active Systems , Ltd. | 2017-02-02 |
| NovaGuard SA Pro Safety System (K163511) | West Pharmaceutical Services, Inc. | 2017-02-02 |
| iHealth Wireless Blood Pressure Monitor (K162144) | Andon Health Co, Ltd. | 2017-02-01 |
| Stealth Staple System (K163440) | First Ray, LLC | 2017-02-01 |
| Exactech® Equinoxe® Preserve Stem (K162726) | Exactech, Inc. | 2017-02-01 |
| VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) (K163083) | bioMerieux, Inc. | 2017-02-01 |
| Life Spine Metatarsal Hemi Implant (K161279) | Life Spine, Inc. | 2017-02-01 |
| PicoWay Laser System (K162454) | Syneron Candela Corporation | 2017-02-01 |
| Memodyn Staple (K161587) | Austin & Associates, Inc./Telos Medical Equipment | 2017-02-01 |
| Twin-Pass Torque (K162467) | Vascular Solutions, Inc. | 2017-02-01 |
| 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 (K162958) | Medtronic, Inc. | 2017-02-01 |
| Lyme B. burgdorferi (IgG) MarStripe Test (K163095) | Trinity Biotech | 2017-02-01 |
| Pre-Formed Penile Silicone Block (K162624) | International Medical Devices, Inc. | 2017-02-01 |
| U2 Total Knee System, PSA Tibial Insert (K161360) | United Orthopedic Corporation | 2017-02-01 |
| Philips CombiDiagnost R90 (K163210) | Philips Medical Systems Dmc GmbH | 2017-01-31 |
| Medline Non-Surgical Isolation Gown- (K160471) | Medline Industries, Inc. | 2017-01-31 |
| Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 (K163170) | Capillus, LLC | 2017-01-31 |
| CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (K163542) | Datascope Corp. | 2017-01-31 |
| HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (K162381) | Healthy Glove Co., Ltd. | 2017-01-31 |
| NobelClinician, DTX Studio implant (K163122) | Nobel Biocare AB | 2017-01-31 |
| Acclarix LX8 Diagnostic Ultrasound System (K162055) | Edan Instruments, Inc. | 2017-01-31 |
| IDS-iSYS Intact PTHN (K161158) | Immunodiagnostic Systems , Ltd. | 2017-01-31 |
| OsteoCool V-3 RF Ablation System (K161949) | Baylis Medical Company, Inc. | 2017-01-31 |
| ET Hybrid Abutment (K162390) | Hiossen, Inc. | 2017-01-30 |
| Radifocus Glidewire Advantage Track (K163004) | Ashitaka Factory of Terumo Coporation | 2017-01-30 |
| Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K163058) | Boston Scientific | 2017-01-30 |
| OBS Electrosurgical Generator (Model: OBS-350A) (K162034) | Baisheng Medical Co., Ltd. | 2017-01-30 |
| LED Phototherapy Device (K162098) | Li-Tek Electronic Technology Corporation | 2017-01-30 |
| Elite Expandable Interbody Fusion Device (K162879) | Spineology, Inc. | 2017-01-30 |
| FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm (K161967) | Callisyn Biomedical, Inc. | 2017-01-27 |
| Advanced Gynecological Applicator (K161688) | Nucletron B.V. | 2017-01-27 |
| VERIFY STEAM Integrating Indicator - Short (K162631) | STERIS Corporation | 2017-01-27 |
| L300 Go System (K162407) | Bioness, Inc. | 2017-01-27 |
| 3M Clear Tray Aligner (K163689) | 3M Unitek Corporation | 2017-01-27 |
| EBM iDO Viewer 1.2.1 (K162285) | Ebm Technologies Incorporated | 2017-01-27 |
| RP Lite 760R (K163280) | Mego Afek AC , Ltd. | 2017-01-27 |