| Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs (K150468) | K2 Medical GmbH & Co. KG | 2016-02-29 |
| syngo.via MI Workflows (K160317) | Siemens Medical Solutions USA, Inc. | 2016-02-29 |
| Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack (K153199) | Kci USA, Inc. | 2016-02-29 |
| BlastGen (K152932) | Origio A/S | 2016-02-29 |
| ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite (K150597) | Phadia AB | 2016-02-29 |
| Vesocclude Polymer Ligating Clip (K152082) | Vesocclude Medical, LLC | 2016-02-26 |
| H3+ Holter Recorder (K152626) | Mortara Instrument, Inc. | 2016-02-26 |
| LOGIQ S7 Expert (K160182) | GE Healthcare | 2016-02-26 |
| Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) (K160173) | Boston Scientific Corporation | 2016-02-26 |
| VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM (K152765) | B. Braun Interventional Systems, Inc. | 2016-02-26 |
| VIVIX-S 1717N (K152894) | Vieworks Co., Ltd. | 2016-02-26 |
| BCR-30-min BI™ and RBIP-ST30™ Readout Accessory (K151482) | Bcr Diagnostics, Inc. | 2016-02-26 |
| Indego (K152416) | Parker Hannifin Corporation | 2016-02-26 |
| TandemLung Oxygenator (K153295) | Cardiacassist, Inc. | 2016-02-26 |
| Sniper (R) Spine System (K160003) | Spine Wave, Inc. | 2016-02-26 |
| Aingeal Activity System (K153275) | Intelesens, Ltd. | 2016-02-26 |
| Illuminated Mediastinal Access Port (K160171) | Aegis Surgical, Ltd. | 2016-02-26 |
| E-CUBE i7 (K153424) | Alpinion Medical Systems Co., Ltd. | 2016-02-26 |
| Beactive Brace (K151476) | Natures Pillows, Inc. | 2016-02-26 |
| VIVIX-S 1012N (K152855) | Vieworks Co., Ltd. | 2016-02-26 |
| THUNDERBEAT Open Fine Jaw (K151743) | Olympus Medical Systems Corp. | 2016-02-26 |
| Calcium Bridge (K153191) | Denali Corporation | 2016-02-26 |
| ICONACY(TM) I-Hip (TM) (K151307) | Iconacy Orthopedic Implants, LLC | 2016-02-26 |
| Tyber Medical Trauma Screw (K153575) | Tyber Medical, LLC | 2016-02-26 |
| Novilase Laser Therapy System, Model LTS-2 (K160392) | Novian Health, Inc. | 2016-02-26 |
| High Pressure Tanning Lamps (K152141) | Blv Licht-Und Vakuumtechnik GmbH | 2016-02-25 |
| Occlusion Perfusion Catheter (K153488) | Advanced Catheter Therapies, Inc. | 2016-02-25 |
| VITAL SIGNS MONITOR (K153135) | Guangdong Biolight Meditech Co., Ltd. | 2016-02-25 |
| IRENE Locking Compression Plate System (K151508) | Tianjin Zhengtian Medical Instrument Co., Ltd. | 2016-02-25 |
| Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570) | Icad, Inc. | 2016-02-25 |
| Mammotome revolve Dual Vacuum Assist Biopsy System (K152989) | Devicor Medical Products, Inc. | 2016-02-25 |
| HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K152715) | Haining Medical Products Co., Ltd. | 2016-02-25 |
| MRCAT (K151435) | Philips Medical Systems MR Finland | 2016-02-25 |
| DIVA ZSP2105CMI with QUBYX PerfectLum bundle (K160328) | The Linden Group Corp | 2016-02-25 |
| Perfectio LED infrared device (K152332) | Omm Imports Inc Dba Zero Gravity | 2016-02-25 |
| BD Veritor System for Rapid Detection of Flu A + B Labratory Kit (K160164) | Becton, Dickinson & CO | 2016-02-25 |
| MedicVOD System (K151737) | Orpheus Medical , Ltd. | 2016-02-25 |
| SIGN Compression Screw System (K153759) | Sign Fracture Care International | 2016-02-25 |
| IMPLANT 3D (K153091) | Media Lab S.R.L. | 2016-02-25 |
| LATEX EXAMINATION GLOVE POWDER FREE (K152593) | Careplus (M) Sdn Bhd | 2016-02-25 |
| ASAHI Astato XS 40 (K153443) | Asahi Intecc Co., Ltd. | 2016-02-25 |
| Voluson S6, Voluson S8, Voluson S10 (K160184) | GE Healthcare | 2016-02-25 |
| Cogent Lateral Interbody System (K151406) | Cogent Spine, LLC | 2016-02-25 |
| SKIN CARE (K152736) | C.I.S, Ltd. | 2016-02-25 |
| The Cellfina System (K153677) | Ulthera, Inc. | 2016-02-25 |
| McLaren Proton Therapy System (K160063) | Mclaren Health Care Corporation | 2016-02-25 |
| BD BACTEC Peds Plus/F Culture Vials (plastic) (K151866) | Becton, Dickinson and Company | 2016-02-25 |
| OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) (K153617) | Boston Scientific Corporation | 2016-02-25 |
| ETView VivaSight-SL (TVT) system (K152438) | Etview , Ltd. | 2016-02-25 |
| EDS Universal Cement (K152691) | Essential Dental Systems, Inc. | 2016-02-25 |
| Strialite (K151337) | Centre Light Solutions, LLC | 2016-02-24 |
| HeartLight Deflectable Sheath (K152310) | Cardiofocus, Inc. | 2016-02-24 |
| EndoChoice Water Bottle Cap System (K153588) | Endochoice, Inc. | 2016-02-24 |
| IV-eye (K152088) | Novarix Limited | 2016-02-24 |
| Liquid CO2-2 (LCO2-2) (K152085) | Randox Laboratories, Ltd. | 2016-02-24 |
| SpineView X-Pac Expandable Lumbar Cage System (K152539) | Spine View, Inc. | 2016-02-24 |
| Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip (K152768) | Assure Tech. Co., Ltd. | 2016-02-24 |
| Oxyless Blood Tubing Set (K150304) | Oxyless, Ltd. | 2016-02-24 |
| BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K160161) | Becton, Dickinson & CO | 2016-02-24 |
| Fujifilm Video Colonoscope Model EC-600WL V2 (K160196) | Fujifilm Medical Systems U.S.A, Inc. | 2016-02-23 |
| Navik 3D (K152160) | Apn Health, LLC | 2016-02-23 |
| UreTron MultiProbe Lithotripter System (K160198) | Med-Sonics Corp. | 2016-02-23 |
| ANI Monitor (K142969) | Mdoloris Medical Systems Sas | 2016-02-23 |
| Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters (K152557) | G21, S.R.L. | 2016-02-23 |
| 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR (K160247) | Eizo Corporation | 2016-02-23 |
| Arthrex Short Suture Anchors (K151092) | Arthrex, Inc. | 2016-02-23 |
| Spot Skan (K152831) | Skanray Technologies Private Limited | 2016-02-23 |
| Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series (K153474) | Biochemical Diagnostics, Inc. | 2016-02-23 |
| Palisade Pedicular Fixation System (K153323) | Spineology, Inc. | 2016-02-23 |
| 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) (K160326) | Jvckenwood Corporation | 2016-02-23 |
| FS-PACS (K152034) | Ec-Web Co., Ltd. | 2016-02-23 |
| twion (K151717) | Alber GmbH | 2016-02-23 |
| PriMatrix Dermal Repair Scaffold (K153690) | Tei Biosciences, Inc. | 2016-02-22 |
| VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (K153548) | Visionsense, Ltd. | 2016-02-22 |
| B.R.A.H.M.S PCT sensitive KRYPTOR (DEN150009) | Brahms GmbH | 2016-02-20 |
| CPX 4 Breast Tissue Expander (K152496) | Mentor Worldwide, LLC | 2016-02-19 |
| Venturi Gauze Wound Care Sets with Portal Drain (K151263) | Talley Group, Ltd. | 2016-02-19 |
| Arthrex iBalance TKA System (K153586) | Arthrex, Inc. | 2016-02-19 |
| ViziShot FLEX (K152922) | Spiration, Inc. | 2016-02-19 |
| InZone Detachment System (K160096) | Stryker Neurovascular | 2016-02-19 |
| Low Potassium Dextran Solution with Tris Diluent (K153384) | United Therapeutics Corporation | 2016-02-19 |
| Epix Electrosurgical Probe with Smoke Evacuation (K151480) | Applied Medical Resources | 2016-02-19 |
| APEX Compounding System Transfer Set (K151423) | B.Braun Medical, Inc. | 2016-02-19 |
| InMode RF System (K151793) | Inmode MD , Ltd. | 2016-02-19 |
| syngo.CT Single Source Dual Energy (Twin Beam) (K153220) | Siemens Medical Solutions USA, Inc. | 2016-02-19 |
| V20 system (K152611) | Viora , Ltd. | 2016-02-19 |
| Ora-GUARD Dental Grind Guard (K150492) | Bite Tech, Inc. | 2016-02-19 |
| ATLANTIS ISUS (K151439) | Dentsply International, Inc. | 2016-02-19 |
| SmartBase for Arthrex Glenoid IRIS (K153215) | Custom Orthopaedic Solutions, Inc. | 2016-02-19 |
| Oscar 2 (K151520) | Suntech Medical, Inc. | 2016-02-19 |
| I4 (Integrated Intelligent Imaging Informatics) system (K160315) | Philips Medical Systems Nederland B.V. | 2016-02-19 |
| Weely Manual Wheelchair (K152827) | Rupiani | 2016-02-19 |
| FreeStyle Precision Neo H Blood Glucose Monitoring System (K153330) | Abbott Diabetes Care, Inc. | 2016-02-19 |
| Recovery Cone Removal System (K152136) | C.R. Bard, Inc. | 2016-02-18 |
| CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems (K153442) | Medtronic Sofamor Danek USA, Inc. | 2016-02-18 |
| Fusion Compact Navigation System (K153247) | Medtronic Navigation, Inc. | 2016-02-18 |
| Arm automatic blood pressure monitor (K151258) | Shenzhen Pump Medical System Co., Ltd. | 2016-02-18 |
| Erchonia EVRL (K152196) | Erchonia Corporation | 2016-02-18 |
| Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (K151474) | Fujifilm Medical System U.S.A., Inc. | 2016-02-18 |
| VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (K151817) | bioMerieux, Inc. | 2016-02-18 |