| Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (K190073) | Current Health , Ltd. | 2019-03-27 |
| Accutorr 7/VS-900/VS-900c Vital Signs Monitor (K182821) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-27 |
| transGlideXT Expandable Introducer (K181817) | Transaortic Medical, Inc. | 2019-03-26 |
| MobileECG 2 BT (K181658) | Memtec Corporation | 2019-03-26 |
| Arm Blood Pressure Monitor (K183491) | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2019-03-24 |
| Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile (K183608) | Scientia Vascular, LLC | 2019-03-22 |
| Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors (K181738) | Surgical Instrument Service and Savings Inc (Dba Medline | 2019-03-22 |
| Polyethylene Catheter (K181722) | Cook Incorporated | 2019-03-22 |
| Telescope Guide Extension Catheter (K183353) | Medtronic, Inc. | 2019-03-22 |
| Masimo Rad-67 Pulse CO-Oximeter and Accessories (K182887) | Masimo Corporation | 2019-03-22 |
| Ballast 088 Long Sheath (K182918) | Balt USA, LLC | 2019-03-21 |
| Route 92 Medical Delivery Catheter (K190431) | Route 92 Medical, Inc. | 2019-03-21 |
| A&D Medical Blood Pressure Monitors (K173191) | A&D Company, Ltd. | 2019-03-21 |
| ExpanSure Transseptal Dilation System (K182064) | Baylis Medical Company, Inc. | 2019-03-21 |
| Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System (K190423) | Devon Medical Products (Jiangsu), Ltd. | 2019-03-19 |
| Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241) (K183511) | Medtronic, Inc. | 2019-03-18 |
| MAMBA and MAMBA Flex Microcatheters (K190401) | Boston Scientific Corporation | 2019-03-15 |
| CardioFlux with Faraday Analytical Cloud (K182571) | Genetesis, Inc. | 2019-03-15 |
| SelectSite C304-HIS Deflectable Catheter System (K183493) | Medtronic, Inc. | 2019-03-15 |
| Omron Model BP7900 Blood Pressure Monitor + EKG (K182579) | Omron Healthcare, Inc. | 2019-03-14 |
| VASOBand Vascular Compression Device (K190318) | Vasoinnovations, Inc. | 2019-03-14 |
| Venture 0.014 Catheter (K182570) | Vascular Solutions, LLC | 2019-03-13 |
| BeneVision Central Monitoring System (K183238) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-13 |
| AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm (K183463) | Stryker | 2019-03-13 |
| AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) (K183464) | Stryker | 2019-03-13 |
| Microlife Digital Blood Pressure Monitor (K183469) | Microlife Intellectual Property GmbH | 2019-03-12 |
| Inno-Pathwire (K182553) | Suzhou Innomed Medical Device Co., Ltd. | 2019-03-11 |
| KardiaAI (K181823) | AliveCor, Inc. | 2019-03-11 |
| iSLEEVE Introducer Set (K190184) | Boston Scientific | 2019-03-07 |
| Philips wearable biosensor-G5 Solution (K181165) | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
| RhythmAnalytics (K182344) | Biofourmis Singapore Pte., Ltd. | 2019-03-07 |
| Endophys Pressure Sensing Sheath (K190098) | Endophys Holdings, LLC | 2019-03-07 |
| VitalConnect Platform, VitalPatch Biosensor (K183078) | Vitalconnect, Inc. | 2019-03-07 |
| Electronic Blood Pressure Monitor (K182495) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2019-03-03 |
| Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System (K182822) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-03-01 |
| Early Bird Bleed Monitoring System (DEN180021) | Saranas, Inc. | 2019-03-01 |
| Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (K183067) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-03-01 |
| EP-TRACER System (K183266) | Schwarzer Cardiotek GmbH | 2019-03-01 |
| Lifetech Cardio Model 8301 Temporary Pacemaker (K182839) | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2019-02-28 |
| QUANTIEN Measurement System (K183099) | St. Jude Medical (Now Abbott Medical) | 2019-02-28 |
| ReDS System (K180479) | Sensible Medical Innovations , Ltd. | 2019-02-28 |
| Lympha Press Optimal Plus (K182003) | Mego Afek AC , Ltd. | 2019-02-27 |
| FlowMet-R (K182494) | Laser Associated Sciences, Inc. | 2019-02-27 |
| CAPERE Thrombectomy System (K183179) | Vascular Medcure, Inc. | 2019-02-25 |
| Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (K183290) | Thrombolex, Inc. | 2019-02-25 |
| Reprocessed Response Diagnostic Electrophysiology Catheter (K182488) | Innovative Health, LLC | 2019-02-22 |
| HeartCheck Cardi Beat ECG Monitor with GEMS Mobile (K181310) | Cardiocomm Solutions, Inc. | 2019-02-22 |
| Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device (K182578) | Devon Medical Products (Jiangsu), Ltd. | 2019-02-21 |
| RX-1 Rhythm Express Remote Cardiac Monitoring System (K183704) | VivaQuant, Inc. | 2019-02-16 |
| oCare Wrist Pulse Oximeter (K183556) | Taiwan Biophotonic Corporation | 2019-02-15 |
| Lunderquist® Fixed Core Wire Guide (K181353) | Cook Incorporated | 2019-02-15 |
| GMC Wrist Automatic Blood Pressure Monitor (K181930) | Gmc, Inc. | 2019-02-14 |
| PhotoFix Decellularized Bovine Pericardium (K183635) | Cryolife, Inc. | 2019-02-14 |
| FORA P100 Blood Pressure Monitoring System (K182934) | Taidoc Technology Corporation | 2019-02-12 |
| IntraSight (K190078) | Volcano Corporation | 2019-02-11 |
| Coala Heart Monitor (K182040) | Coala Life AB | 2019-02-08 |
| AcQMap High Resolution Imaging and Mapping System (K181577) | Acutus Medical, Inc. | 2019-02-07 |
| WavelinQ 4F EndoAVF System (K182796) | C.R. Bard, Inc. | 2019-02-06 |
| Patient Cables and Leadwires , Disposable ECG Leadwires (K182327) | Orantech, Inc. | 2019-01-30 |
| ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 (K183070) | Asahi Intecc Co., Ltd. | 2019-01-29 |
| ZOLL ECG Analysis Software (K182093) | Zoll Manufacturing Corporation | 2019-01-28 |
| medi pneumatic compression system (pcs) – brio (Model 651) (K183631) | Medi USA, LP | 2019-01-25 |
| Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (K183615) | Avenu Medical, Inc. | 2019-01-25 |
| Reprocessed CS Diagnostic Electrophysiology Catheter (K181056) | Stryker Sustainability Solutions | 2019-01-24 |
| Surveyor S2 (K182297) | Mortara Instrument, Inc. | 2019-01-24 |
| Masimo MightySat Rx Fingertip Pulse Oximeter (K181956) | Masimo Corporation | 2019-01-23 |
| XableCath Crossing Catheter (K183357) | Xablecath, Inc. | 2019-01-21 |
| Reprocessed Visions PV .035 Digital IVUS Catheter (K181126) | Innovative Health, LLC | 2019-01-18 |
| Study Watch (K182456) | Verily Life Sciences, LLC | 2019-01-17 |
| Roadrunner Extra Support Wire Guide (K183467) | Cook Incorporated | 2019-01-11 |
| INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor (K182868) | Covidien, LLC | 2019-01-08 |
| Arm Blood Pressure Monitor (K180435) | Alicn Medical (Shenzhen), Inc. | 2019-01-03 |
| ViperCath XC Peripheral Exchange Catheter (K183000) | Cardiovascular Systems, Inc. | 2018-12-29 |
| COR12 ECG (K183369) | Corscience GmbH & Co. | 2018-12-28 |
| VO200 – NeurOs Cerebral Oximetry System (K182242) | Mespere Lifesciences, Inc. | 2018-12-26 |
| vital signs monitor (K180380) | Edan Instruments, Inc. | 2018-12-21 |
| Pulse Rx 2.0, Pulse Pro Rx 2.0 (K183328) | NormaTec Industries, LP | 2018-12-21 |
| The ICHOR Panacea Vascular Embolectomy Catheter System (K182167) | Ichor Vascular, Inc. | 2018-12-21 |
| North-vision Multi-parameter Patient Monitor (K173036) | North-Vision Tech., Inc. | 2018-12-21 |
| ASAHI Corsair Pro XS (K182420) | Asahi Intecc Co., Ltd. | 2018-12-20 |
| Reuter Tip Deflecting Wire Guide (K180830) | Cook Incorporated | 2018-12-20 |
| Phoenix Atherectomy System (K182972) | Volcano Atheromed, Inc. | 2018-12-20 |
| Dilator Sets (K183036) | Cook Incorporated | 2018-12-20 |
| DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System (K183267) | Osprey Medical, Inc. | 2018-12-20 |
| FFRangio System (K182149) | Cathworks, Ltd. | 2018-12-19 |
| Arterial Pressure Monitoring Set/Tray (K180846) | Cook Incorporated | 2018-12-19 |
| Devon 52 Sequential Compression Device (K182150) | Devon Medical Products (Jiangsu), Ltd. | 2018-12-18 |
| Riptide Aspiration System (Riptide Large Bore Aspiration System) (K183185) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-12-18 |
| Handheld VitalSigns Monitoring System (K172965) | Visiomed Technology Co.,Ltd | 2018-12-17 |
| FlowTriever Retrieval/Aspiration System (K183198) | Inari Medical | 2018-12-17 |
| Reusable Silicone Cover CPRmeter 2 (K183348) | Laerdal Medical AS | 2018-12-17 |
| Tyto Stethoscope (OTC) (K181612) | Tyto Care , Ltd. | 2018-12-17 |
| Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff (K182433) | Shenzhen Caremed Medical Technology Co., Ltd. | 2018-12-17 |
| Phoenix 2.4mm Atherectomy Plus System (K181877) | Volcano Atheromed, Inc. | 2018-12-17 |
| Cardio-TriTest v6.5 (K182790) | Cardio-Phoenix, Inc. | 2018-12-14 |
| Xcess Guiding Catheter (K180797) | Curatia Medical Co. | 2018-12-14 |
| 3880 MRI Patient Monitoring System (K182900) | Iradimed Corporation | 2018-12-14 |
| UniPulse (K182905) | Seaward Group | 2018-12-14 |
| iCertainty (K181269) | Rfpi | 2018-12-14 |
| Argos (K181372) | Retia Medical, LLC | 2018-12-13 |