| NovaCross Microcatheter (K160389) | Nitiloop , Ltd. | 2016-03-11 |
| ENROUTE Transcarotid Neuroprotection System (K153485) | Silk Road Medical, Inc. | 2016-03-10 |
| Reprocessed Diagnostic Ultrasound Catheter (K153090) | Innovative Health, LLC | 2016-03-10 |
| MMS Guide Catheter (K152625) | Micro Medical Solutions, Inc. | 2016-03-09 |
| Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select (K153430) | Cook Incorporated | 2016-03-07 |
| Bead Block (K150876) | Biocompatibles UK , Ltd. | 2016-03-07 |
| ASAHI Corsair Armet (K152249) | Asahi Intecc Co., Ltd. | 2016-03-04 |
| PROTEK Duo 31 Fr. Veno-Venous Cannula Set (K160257) | Cardiacassist, Inc. | 2016-03-04 |
| MultiCross Catheter (K152957) | Roxwood Medical, Inc. | 2016-03-04 |
| Endophys Pressure Sensing Sheath Kit (K160272) | Endophys, Inc. | 2016-03-04 |
| Passport Series Patient Monitors (Including Passport 8, Passport 12) (K153448) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-03-03 |
| Finger Type Pulse Oximeter (K151024) | Taidoc Technology Corporation | 2016-03-02 |
| Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) (K153460) | Avinger, Inc. | 2016-03-01 |
| H3+ Holter Recorder (K152626) | Mortara Instrument, Inc. | 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 |
| TandemLung Oxygenator (K153295) | Cardiacassist, Inc. | 2016-02-26 |
| Aingeal Activity System (K153275) | Intelesens, Ltd. | 2016-02-26 |
| Occlusion Perfusion Catheter (K153488) | Advanced Catheter Therapies, Inc. | 2016-02-25 |
| VITAL SIGNS MONITOR (K153135) | Guangdong Biolight Meditech Co., Ltd. | 2016-02-25 |
| ASAHI Astato XS 40 (K153443) | Asahi Intecc Co., Ltd. | 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 |
| HeartLight Deflectable Sheath (K152310) | Cardiofocus, Inc. | 2016-02-24 |
| Navik 3D (K152160) | Apn Health, LLC | 2016-02-23 |
| ANI Monitor (K142969) | Mdoloris Medical Systems Sas | 2016-02-23 |
| Spot Skan (K152831) | Skanray Technologies Private Limited | 2016-02-23 |
| Oscar 2 (K151520) | Suntech Medical, Inc. | 2016-02-19 |
| Recovery Cone Removal System (K152136) | C.R. Bard, Inc. | 2016-02-18 |
| Arm automatic blood pressure monitor (K151258) | Shenzhen Pump Medical System Co., Ltd. | 2016-02-18 |
| Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) (K152902) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-02-18 |
| FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm (K152485) | Ostial Corporation | 2016-02-16 |
| FUSION Vascular Graft (K153523) | Maquet Cardiovascular, LLC | 2016-02-16 |
| Star 60 (K151512) | Skanray Technologies Private Limited | 2016-02-14 |
| Digital Electrocardiograph (K160092) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2016-02-12 |
| Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire (K152231) | Boston Scientific Corporation | 2016-02-12 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077) | Microlife Intellectual Property GmbH | 2016-02-12 |
| Masimo Root Vital Signs Monitoring System and Accessories (K151644) | Masimo Corporation | 2016-02-12 |
| PTFE Super Sheath Introducer 2.1 (K153246) | Medcomp (Medical Components, Inc.) | 2016-02-12 |
| OptoWire Deux (K152991) | Opsens | 2016-02-11 |
| Dictum Health (K152645) | Dictum Health, Inc. | 2016-02-09 |
| PC ECG (K152427) | Edan Instruments, Inc. | 2016-02-05 |
| Vital Signs Patch System (K151835) | Lifewatch Technologies , Ltd. | 2016-02-05 |
| Bridge Occlusion Balloon (K153530) | Spectranetics, Inc. | 2016-02-05 |
| DyeVert Contrast Modulation System (K153141) | Osprey Medical, Inc. | 2016-02-04 |
| CorMatrix Tyke (K152127) | Cormatrix Cardiovascular, Inc. | 2016-02-04 |
| iHealth Track Blood Pressure Monitor (K160014) | Andon Health Co, Ltd. | 2016-02-02 |
| Hansen Medical Magellan Robotic Catheter eKit (K153304) | Hansen Medical, Inc. | 2016-02-01 |
| ROSC-U Mini Chest Compressor (RMCC) (K153628) | Resuscitation International, LLC | 2016-01-30 |
| Holter System (K151787) | Edan Instruments, Inc. | 2016-01-27 |
| 8F FlowGate2 Balloon Guide Catheter (K153729) | Concentric Medical | 2016-01-27 |
| PATIENT MONITORS VARIOUS MODELS (K151812) | Philips Medical Systems | 2016-01-26 |
| CenterCross Ultra Catheter (K152456) | Roxwood Medical, Inc. | 2016-01-26 |
| ASAHI Caravel (K152447) | Asahi Intecc Co., Ltd. | 2016-01-22 |
| PW Guidewires (K152497) | Tatara Vascular, LLC | 2016-01-22 |
| CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set (K151048) | Bracco Injeneering | 2016-01-22 |
| Crosperio RX PTA Balloon Dilatation Catheter (K152887) | KANEKA Corporation | 2016-01-22 |
| Livewire Electrophysiology Catheter (K151617) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2016-01-22 |
| Crosstella RX Balloon Dilatation Catheter (K152873) | KANEKA Corporation | 2016-01-22 |
| Pruitt F3-S Polyurethane Carotid Shunt (K152833) | LeMaitre Vascular, Inc. | 2016-01-21 |
| basixTOUCH40 Inflation Syringe (K153672) | Merit Medical Systems, Inc. | 2016-01-20 |
| Flo Trac sensor, Volume View sensor (K152980) | Edwards Lifesciences, LLC | 2016-01-19 |
| True Flow Valvuloplasty Perfusion Catheter (K152613) | C.R. Bard, Inc. | 2016-01-19 |
| Medtronic Bio-Medicus Adult Cannula Kit (K153598) | Medtronic, Inc. | 2016-01-15 |
| ECG Mini System Continuous ECG Monitor and Arrhythmia Detector (K151269) | Lifewatch Technologies , Ltd. | 2016-01-15 |
| Esophageal Cooling Device (K152450) | Advanced Cooling Therapy, LLC | 2016-01-15 |
| OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System (K152361) | Liebel-Flarsheim Company, LLC | 2016-01-14 |
| Cronus HP - High Pressure Peripheral Balloon Catheter (K151141) | Nipro Medical Corporation | 2016-01-14 |
| Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (K152541) | Penumbra, Inc. | 2016-01-13 |
| FFRct (K152733) | HeartFlow, Inc. | 2016-01-13 |
| IntraNovo Microcatheter (K153125) | Texasmedical Technologies, Inc. | 2016-01-13 |
| MUSE Cardiology Information System (K152993) | Ge Medical Systems Information Technologies, Inc. | 2016-01-12 |
| Fortress Introducer Sheath SYstem (K153197) | Contract Medical International, GmbH | 2016-01-11 |
| LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM (K152876) | Tni Manufacturing, Inc. | 2016-01-08 |
| Full Automatic (NIBP) Blood Pressure Monitor (K153214) | Health & Life Co., Ltd. | 2016-01-07 |
| Sterile High-pressure Angiographic Syringes for Single-use (K151960) | Shenzhen Baoan Medical Supplies Co., Ltd. | 2016-01-07 |
| Edwards Balloon Catheter (K153069) | Edwards Lifesciences | 2016-01-07 |
| ClariVein IC (K153502) | Vascular Insights, LLC | 2016-01-06 |
| Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D (K151287) | Guangdong Biolight Meditech Co., Ltd. | 2016-01-06 |
| Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems (K152944) | Mortara Instrument, Inc. | 2016-01-06 |
| VasoStat Hemostasis Device (K153259) | Forge Medical, Inc. | 2016-01-06 |
| SoloPath Re-Collapsible Access System (K152498) | Onset Medical Corporation | 2016-01-05 |
| Visions PV .035 Digital IVUS Catheter (K153094) | Volcano Corporation | 2015-12-31 |
| Traxcess Pro 14 Guidewire (K153053) | MicroVention, Inc. | 2015-12-29 |
| Solitaire Platinum Revascularization Device (K153071) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-12-23 |
| Expression MR400 MRI Patient Monitoring System (K152330) | Invivo Corporation | 2015-12-23 |
| Cerner CareAware Event Management (K151672) | Cerner Corporation | 2015-12-21 |
| HydroPearl Microspheres, HydroPearl Microspheres (K150870) | MicroVention, Inc. | 2015-12-21 |
| Defibrillator Analyzer Variable Load (K153210) | Bc Group International, Inc. | 2015-12-21 |
| Fluent Inflation Device (K152387) | Vascular Solutions, Inc. | 2015-12-18 |
| MReye Embolization Coils (K150931) | Cook Incorporated | 2015-12-18 |
| MReye Flipper Detachable Embolization Coil and Delivery System (K150964) | Cook Incorporated | 2015-12-18 |
| Digital Electrocardiograph (K152384) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-12-18 |
| Foresight Intracardiac Echocardiography (ICE) System (K151126) | Colibri Technologies, Inc. | 2015-12-18 |
| V8 Balloon Aortic Valvuloplasty Catheter (K152150) | Intervalve, Inc. | 2015-12-18 |
| MoMe Software Platform (K152491) | Infobionic, Inc. | 2015-12-17 |
| Bpump Blood Pressure Cuff (K151810) | Shenzhen Pump Medical System Co., Ltd. | 2015-12-17 |
| Renew NCP-5 External Counterpulsation System (K152115) | Stage 2 Innovations | 2015-12-17 |
| Vios Monitoring System (K150992) | Vios Medical, Inc. | 2015-12-16 |
| PulseFlowDF (K150806) | Pulseflow Technologies | 2015-12-16 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153450) | Microlife Intellectual Property GmbH | 2015-12-16 |