| Kent Camera (K163070) | Kent Imaging, Inc. | 2017-05-05 |
| A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor (K163683) | A&D Company, Ltd. | 2017-05-03 |
| The IQool System (K162523) | Braincool AB | 2017-05-03 |
| CardioCel 3D (K170951) | Admedus Regen Pty, Ltd. | 2017-04-28 |
| IOB Temperature Management System (K162679) | Iob Medical, Inc. | 2017-04-28 |
| van Andel Dilatation Catheter (K170616) | Cook Incorporated | 2017-04-28 |
| Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters (K161596) | AngioDynamics, Inc. | 2017-04-28 |
| ECG Disposable Lead Wire (K170536) | APK Technology Co., Ltd. | 2017-04-24 |
| CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor (K163255) | Caretaker Medical, LLC | 2017-04-21 |
| Nexxis OR, Nexxis (K170537) | Barco N.V. | 2017-04-21 |
| Penumbra 3D Revascularization Device (K162901) | Penumbra, Inc. | 2017-04-20 |
| HEM-9210T (K163235) | Omron Healthcare, Inc. | 2017-04-20 |
| BeneVision Central Monitoring System (K162607) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-04-20 |
| Finapres Nova Noninvasive Hemodynamic Monitor (K160967) | Finapres Medical Systems B.V. | 2017-04-18 |
| Plato MICROCATH 27B Microcatheter (K170406) | Scientia Vascular, LLC | 2017-04-18 |
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable (K163381) | Edwards Lifesciences, LLC | 2017-04-14 |
| Spectranetics Turbo-Elite Laser Atherectomy Catheters (K170059) | Spectranetics, Inc. | 2017-04-07 |
| RX Takeru Balloon Dilatation Catheter (K163372) | KANEKA Corporation | 2017-04-07 |
| MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter (K163233) | Mivi Neuroscience, Inc. | 2017-04-06 |
| Inqwire Diagnostic Guide Wire (K170700) | Merit Medical Systems, Inc. | 2017-04-06 |
| AcQGuide Steerable Sheath (K162925) | Acutus Medical, Inc. | 2017-04-06 |
| HeartSpan Steerable Sheath Introducer (K170668) | Merit Medical Systems, Inc. | 2017-04-05 |
| Arm automatic blood pressure monitor (K161712) | Shenzhen Pump Medical System Co., Ltd. | 2017-04-05 |
| ER-REBOA Catheter (K170411) | Prytime Medical Devices, Inc. | 2017-04-04 |
| Nihon Kohden Vital Sign Telemeter (K163459) | Nihon Kohden Corporation | 2017-04-04 |
| ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (K163426) | Asahi Intecc Co., Ltd. | 2017-04-03 |
| AC3 Series IABP System (K162820) | Arrow International, Inc. | 2017-03-31 |
| BioMonitor 2-AF, BioMonitor 2-S (K170628) | Biotronik, Inc. | 2017-03-31 |
| SureSigns VS3; SureSigns VS4 (K163649) | Philips Medical Systems | 2017-03-31 |
| Bluetooth blood pressure monitor (K161530) | Shenzhen Kingyield Technology Co., Ltd. | 2017-03-31 |
| Chameleon PTA Balloon Catheter (K170635) | Av Medical Technologies, Ltd. | 2017-03-30 |
| Esophageal Cooling Device (K170009) | Advanced Cooling Therapy, LLC | 2017-03-30 |
| Foresight Intracardiac Echocardiology (ICE) System (K162789) | Conavi Medical, Inc. | 2017-03-28 |
| FFR Link, FFR Signal Processing Module (K170204) | Boston Scientific Corporation | 2017-03-24 |
| Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software (K162503) | Cardiac Insight, Inc. | 2017-03-24 |
| CardioDay V2.5 (K162023) | Getemed Medizin- Und Informationstechnik AG | 2017-03-24 |
| Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter (K163314) | Boston Scientific Corporation | 2017-03-23 |
| Fathom-16 Steerable Guidewires (K170636) | Boston Scientific Corporation | 2017-03-22 |
| HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm (K163608) | Biostable Science & Engineering, Inc. | 2017-03-21 |
| Consult Station TS (K153600) | H4D Sas | 2017-03-17 |
| OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY (K162562) | Bcg Medical, LLC | 2017-03-17 |
| Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (K170583) | Medtronic, Inc. | 2017-03-17 |
| NIVR58-T kit (K161880) | Barco N.V. | 2017-03-14 |
| Adscope 658 Electronic Stethoscope (K162589) | American Diagnostic Corp. | 2017-03-10 |
| RHYTHMIA HDx Mapping System (K162793) | Boston Scientific Corporation | 2017-03-10 |
| Mikro-Cath Pressure Catheter (K163376) | Millar, Inc. | 2017-03-10 |
| PhotoFix Decellularized Bovine Pericardium (K162506) | Cryolife, Inc. | 2017-03-09 |
| Solitaire Platinum Revascularization Device, 6x40 mm (K160641) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-03-08 |
| Expro Elite Snare, Sympro Elite Snare (K163307) | Vascular Solutions, Inc. | 2017-03-08 |
| INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (K161733) | Sorin Group Italia S.R.L. | 2017-03-08 |
| DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System (K163054) | Osprey Medical, Inc. | 2017-03-08 |
| CenterCross Ultra LV Catheter (K170403) | Roxwood Medical, Inc. | 2017-03-07 |
| RenovoCath (K160067) | Renovorx, Inc. | 2017-03-07 |
| Vado Steerable Sheath (K160721) | Kalila Medical, Inc. | 2017-03-07 |
| AZUR CX Detachable 18 Peripheral Coil System (K162524) | MicroVention, Inc. | 2017-03-03 |
| Inqwire Diagnostic Guide Wire (K163575) | Merit Medical Systems, Inc. | 2017-03-03 |
| Guardian Angel GA1000 Digital Vital Sign Monitoring System (K162580) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2017-03-03 |
| CareLink SmartSync Device Manager - Pacing System Analyzer (K163008) | Medtronic, Inc. | 2017-02-28 |
| FIRMap Catheter (K163709) | Abbott Electrophysiology | 2017-02-28 |
| Flextra Steerable Introducer (K170373) | Rhythm Xience, Inc. (Rxi) | 2017-02-27 |
| EkoSonic Endovascular System with Control Unit 4.0 (K162771) | Btg International, Inc. | 2017-02-24 |
| Reveal LINQ (K162855) | Medtronic, Inc. | 2017-02-23 |
| my Patch sl (K163535) | Dms-Service, LLC | 2017-02-22 |
| Omron HEM-6400T-Z Wrist Blood Pressure Monitor (K163045) | Omron Healthcare, Inc. | 2017-02-21 |
| SpeedLyser Infusion Catheter Kit (K170258) | AngioDynamics, Inc. | 2017-02-21 |
| ClearLumen II Peripheral Thrombectomy System (K163051) | Walk Vascular, LLC | 2017-02-21 |
| VIA 17 Microcatheter (K162565) | Sequent Medical, Inc. | 2017-02-18 |
| Sentry IVC filter (K162875) | Novate Medical , Ltd. | 2017-02-17 |
| ClotTriever Thrombectomy System (K163549) | Inari Medical, Inc. | 2017-02-16 |
| RF1400 Active Compression Wrap (K162481) | Recovery Force, LLC | 2017-02-16 |
| PC ECG (K160876) | Edan Instruments, Inc. | 2017-02-15 |
| Fully Automatic Electronic Blood Pressure Monitor (K162668) | Andon Health Co, Ltd. | 2017-02-14 |
| Reveal LINQ Insertable Cardiac Monitor (K163460) | Medtronic, Inc. | 2017-02-14 |
| Serranator Alto PTA Serration Balloon Catheter (K163380) | Cagent Vascular, LLC | 2017-02-13 |
| Advance 14LP Low Profile PTA Balloon Dilatation Catheter (K170193) | Cook Incorporated | 2017-02-13 |
| Blood Pressure Monitor (K162089) | Beijing Choice Electronic Technology Co., Ltd. | 2017-02-10 |
| MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) (K162774) | Medtronic, Inc. | 2017-02-10 |
| AcuNav Volume ICE Catheter (K163478) | Siemens Medical Solutions USA, Inc. | 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 |
| 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 |
| Telemetry Transmitter (K161056) | Edan Instruments, Inc. | 2017-02-03 |
| TrapLiner catheter (K161901) | Vascular Solutions, Inc. | 2017-02-03 |
| FlexCath Select Steerable Shealth and Dilator (K163268) | Medtronic Cryocath, LP | 2017-02-02 |
| iHealth Wireless Blood Pressure Monitor (K162144) | Andon Health Co, Ltd. | 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 |
| CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (K163542) | Datascope Corp. | 2017-01-31 |
| Radifocus Glidewire Advantage Track (K163004) | Ashitaka Factory of Terumo Coporation | 2017-01-30 |
| FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm (K161967) | Callisyn Biomedical, Inc. | 2017-01-27 |
| Philips IntelliVue GuardianSoftware (K161767) | Philips Medizin Systeme Boeblingen GmbH | 2017-01-27 |
| ASAHI PTCA Guide Wire ASAHI SUOH 03 (K162842) | Asahi Intecc Co., Ltd. | 2017-01-27 |
| Vado Bi-Directional Steerable Sheath (K162427) | Kalila Medical, Inc. | 2017-01-27 |
| Ecomed Disposable Angiographic Syringes (K162088) | Ecomed Solutions, LLC | 2017-01-27 |
| Pantera LEO (K163660) | Biotronik, Inc. | 2017-01-26 |
| IntraClude Intra-Aortic Occlusion Device (K163693) | Edwards Lifesciences, LLC | 2017-01-26 |
| PreludeSYNC Radial Compression Device (K162988) | Merit Medical Systems, Inc. | 2017-01-25 |
| Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (K163113) | Grandway Technology (Shenzhen) Limited | 2017-01-19 |
| NC Gallant PTCA Catheter (K162434) | Medinol, Ltd. | 2017-01-19 |
| Medline Waste Station (K160660) | Medline Industries, Inc. | 2017-01-19 |