| K162331 — Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid Feb 9, 2017 |
| K163341 — syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. Feb 9, 2017 |
| K161491 — Scopis Hybrid Navigation System EM | Scopis GmbH Feb 9, 2017 |
| K161810 — BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson Feb 9, 2017 |
| K162158 — Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. Feb 9, 2017 |
| K161861 — APTUS® Coronoid 2.0 | Medartis AG Feb 9, 2017 |
| K163289 — syngo. CT Single Source Dual Energy (twin beam) | Siemens Medical Solutions USA, Inc., Ultrasound DI Feb 9, 2017 |
| K170091 — UA-Cellular Complete | Streck Feb 9, 2017 |
| K170113 — pixium 4343RCE | Philips Medical Systems Dmc GmbH Feb 9, 2017 |
| K162611 — PeriFLEX | Spiration, Inc. Feb 9, 2017 |
| K163478 — AcuNav Volume ICE Catheter | Siemens Medical Solutions USA, Inc. Feb 9, 2017 |
| K163184 — cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. Feb 9, 2017 |
| K163566 — Hubble I System | Orbbo Surgical, LLC Feb 9, 2017 |
| K161334 — RASL Repair Kit | Radicle Orthopaedics, Inc. Feb 9, 2017 |
| K163046 — DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long | DePuy Synthes Feb 9, 2017 |
| K162840 — Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 | Roche Diagnostics Feb 8, 2017 |
| K162852 — Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove | Lucenxia Prescience AG Feb 8, 2017 |
| K162915 — Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. Feb 8, 2017 |
| K161432 — MyNeWT Negative Pressure Wound Therapy System | Stortford Medical, LLC Feb 8, 2017 |
| K162491 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Hartalega Sdn Bhd Feb 8, 2017 |
| K163703 — VIVIX-S 1417N | Vieworks Co., Ltd. Feb 8, 2017 |
| K162479 — Smart Pain Reliever, Model LT5019 | Shenzhen Dongdixin Technology Co., Ltd. Feb 8, 2017 |
| K160444 — FB-U Hemodialyzer | Nipro Medical Corporation Feb 8, 2017 |
| K163173 — Handheld Diode Laser for Hair Removal | Liaoning Sidey Optoelectronics Technologies Co., Ltd. Feb 8, 2017 |
| K161468 — Transformair Indoor Air Purifier | Transformair, LLC Feb 8, 2017 |
| K162039 — OptosAdvance 4.0 Software | Optos Plc. Feb 8, 2017 |
| K161577 — Arm-Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. Feb 8, 2017 |
| K162639 — Proficient Posterior Cervical Spine System | Spine Wave, Inc. Feb 7, 2017 |
| K161715 — EndyGel | Endymed Medical, Ltd. Feb 7, 2017 |
| K163214 — Unicare System, Unicare Manipulator | Clearpath Surgical, Inc. Feb 7, 2017 |
| K170072 — Fitmore® Hip Stem | Zimmer GmbH Feb 7, 2017 |
| K161980 — Fuselier Intraoral Nighttime Device (FIND) | Fuselier Enterprises, LLC Feb 7, 2017 |
| K163169 — Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | Cook Ireland, Ltd. Feb 7, 2017 |
| K153262 — PUREtrace | Nemo Healthcare BV Feb 7, 2017 |
| DEN160016 — Variola virus Real-Time PCR Assay | Centers For Disease Control And Prevention (CDC) Feb 6, 2017 |
| K160934 — UC-CARE NaviGo Workstation | UC-CARE , Ltd. Feb 6, 2017 |
| K162973 — EndoWrist Suction Irrigator | Intuitive Surgical, Inc. Feb 6, 2017 |
| K163294 — syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. Feb 6, 2017 |
| K162014 — 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.) | Bluepoint Medical GmbH & Co. KG Feb 6, 2017 |
| K163061 — Altus Spine Cervical Plate System | Altus Partners, LLC Feb 6, 2017 |
| K162283 — DCM Kyphoplasty System | Dragon Crown Medical Co., Ltd. Feb 6, 2017 |
| K162923 — 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 | Hartalega NGC Sdn. Bhd. Feb 6, 2017 |
| K170330 — 3M Protemp Cement Temporary Dental Cement | 3M Company Feb 6, 2017 |
| DEN150035 — SEEKER System | Baebies, Inc. Feb 3, 2017 |
| K161025 — priti multidisc ZrO2 High Translucent | Pritidenta GmbH Feb 3, 2017 |
| K152432 — ActiPatch(R) | Bioelectronics Corporation Feb 3, 2017 |
| K163551 — LenSx Laser System | Alcon Laboratories, Inc. Feb 3, 2017 |
| K162536 — GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord | Kerr Corporation Feb 3, 2017 |
| K163452 — PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. Feb 3, 2017 |
| K161056 — Telemetry Transmitter | Edan Instruments, Inc. Feb 3, 2017 |