| InBody (K200442) | Inbody Co., Ltd. | 2020-12-04 |
| Auryon Atherectomy System (K202835) | Eximo Medical, Ltd. | 2020-12-02 |
| Confirm Rx Insertable Cardiac Monitor (K202876) | Abbott (St. Jude Medical) | 2020-12-01 |
| AcQMap High Resolution Imaging and Mapping System (K201015) | Acutus Medical, Inc. | 2020-12-01 |
| Spo2 Sensor (K202851) | Jkh USA, LLC | 2020-11-27 |
| Pulse Oximeter (K201294) | Guangdong Long Yao Electronic Technology Co., Ltd. | 2020-11-27 |
| EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (K202066) | ABBOTT MEDICAL | 2020-11-25 |
| T3 Platform software (K202306) | Etiometry, Inc. | 2020-11-25 |
| CARTO® 3 EP Navigation System with Signal Processing Unit (K200484) | Biosense Webster, Inc. | 2020-11-25 |
| CADScor System (DEN190047) | Acarix A/S | 2020-11-24 |
| eKuore One Wireless Electronic Interface for stethoscope (K201742) | Chip Ideas Electronics S.L. | 2020-11-24 |
| OptoMonitor 3 (K202943) | Opsens, Inc. | 2020-11-24 |
| Confirm Rx Insertable Cardiac Monitor (K202888) | Abbott (St. Jude Medical) | 2020-11-23 |
| Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (K202042) | Innovative Health, LLC | 2020-11-20 |
| Passio Pump Drainage System (K201404) | Bearpac Medical | 2020-11-20 |
| Fortress Introducer Sheath System (K203179) | Contract Medical International, GmbH | 2020-11-20 |
| MPS 3 ND Myocardial Protection System (K201984) | Quest Medical, Inc. | 2020-11-20 |
| DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (K203008) | Cardiovascular Systems, Inc. | 2020-11-19 |
| Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 (K202821) | Penumbra, Inc. | 2020-11-18 |
| Pacific Plus PTA Catheter (K202800) | Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) | 2020-11-18 |
| R501 aortic root cannula without vent line, R502 aortic root cannula with vent line (K200612) | Sorin Group Italia S.R.L. | 2020-11-17 |
| JETi AIO Peripheral Thrombectomy System (K201998) | Walk Vascular, LLC | 2020-11-17 |
| Cordiana Dx16 (K201060) | Cordiana Medical Informatics AG | 2020-11-16 |
| Acumen Assisted Fluid Management (AFM) Software Feature (DEN190029) | Edwards Lifesciences | 2020-11-13 |
| CoroFlow Cardiovascular System (K201881) | Coroventis Research AB | 2020-11-13 |
| FlexCath Advance Steerable Sheath and Dilator (K202620) | Medtronic Cryocath, LP | 2020-11-13 |
| NOVA Patient Warming System (K203085) | Encompass Group, LLC | 2020-11-12 |
| KardiaAI (K201985) | AliveCor, Inc. | 2020-11-12 |
| Route 92 Medical 070 Access System (K203043) | Route 92 Medical, Inc. | 2020-11-11 |
| SnapshotNIR (K201976) | Kent Imaging | 2020-11-10 |
| SimpleSENSE (K201669) | Nanowear, Inc. | 2020-11-06 |
| LOBO Vascular Occlusion System (model LOBO-5) (K203025) | Okami Medical | 2020-11-05 |
| Monitor B125, Monitor B105 (K201941) | Ge Medical Systems Information Technologies, Inc. | 2020-11-04 |
| eKuore Pro Series (K203007) | Chip Ideas Electronics S.L. | 2020-10-30 |
| Aulisa Multiple Patient Digital Vital Sign Monitoring System (K202497) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020-10-30 |
| Patent Hemostasis Band (PH Band) (K201695) | Medical Ingenuities | 2020-10-30 |
| eCordum Cardiac Monitor (eCordum CM) (K193296) | Ecordum, Inc. | 2020-10-30 |
| Smart Alarm Interface (K193421) | Boxview, LLC | 2020-10-30 |
| Sterile High-pressure Angiographic Syringes for single-use (K201395) | Youwo (Guangzhou) Medical Device Co., Ltd. | 2020-10-28 |
| coraForce and coraFlex Support Catheters (K201811) | Reflow Medical, Inc. | 2020-10-26 |
| Drakon and Sequre Microcatheters (K202797) | Accurate Medical Therapeutics, Ltd. | 2020-10-23 |
| OXY-1 System (K200109) | Abiomed, Inc. | 2020-10-23 |
| Selectra 3D Outer Guiding Catheters (K193474) | Biotronik, Inc. | 2020-10-16 |
| Quantum Ventilation Module (K202733) | Spectrum Medical , Ltd. | 2020-10-16 |
| Merit Hydrophilic Guide Wire (K201595) | Merit Medical Systems, Inc. | 2020-10-14 |
| Stethee Pro 1, Stethee Pro Software System (K193631) | M3Dicine Pty , Ltd. | 2020-10-09 |
| SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter (K201377) | Cordis Corporation | 2020-10-09 |
| Multi-LinkTM X2 ECG Adapter and Leadwires (K200510) | Vyaire Medical, Inc. | 2020-10-09 |
| V20, V20a, AVSM3 SNF (K200434) | Mediana Co., Ltd. | 2020-10-09 |
| ECG App (K201525) | Apple, Inc. | 2020-10-08 |
| TruForm Sievers Annuloplasty Ring (K202253) | Genesee Biomedical, Inc. | 2020-10-06 |
| iSleeve Introducer Set (K202584) | Boston Scientific Corporation | 2020-10-06 |
| Quantum Workstation 12 Elite (K202557) | Spectrum Medical , Ltd. | 2020-10-02 |
| ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device (K202218) | Boston Scientific Corporation | 2020-10-02 |
| SOZO Body Fluid Analyzer (K193410) | ImpediMed Limited | 2020-10-02 |
| ECG Cables and Leadwires (K201359) | Xinkang Medical Instrument Co. , Ltd. | 2020-10-01 |
| HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446) | Edwards Lifesiences, LLC | 2020-10-01 |
| PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph (K191738) | Philips Medical Systems | 2020-09-29 |
| OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K202543) | Volcano Corporation | 2020-09-28 |
| RIST Radial Access Catheter (K201682) | Rist Neurovascular, Inc. | 2020-09-28 |
| Synchro SELECT Guidewire (K202522) | Stryker Neurovascular | 2020-09-25 |
| Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor (K201770) | Masimo Corporation | 2020-09-24 |
| Pulse Oximeter (K200414) | Shenzhen Aeon Technology Co., Ltd. | 2020-09-23 |
| Halo AF Detection System (K201208) | Livmor | 2020-09-23 |
| Pounce Thrombus Retrieval System (K192814) | Surmodics,Inc. | 2020-09-21 |
| Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B (K201467) | Bioland Technology, Ltd. | 2020-09-21 |
| B&J DVT Calf/Thigh Garments, Models 801/830 Series (K201532) | B&J Manufacturing , Ltd. | 2020-09-19 |
| Paragon Adult Maxi PMP Oxygenator with Tubing Pack (K201642) | Chalice Medical , Ltd. | 2020-09-18 |
| B&J DVT Foot Garments, Models 820 Series (K201547) | B&J Manufacturing , Ltd. | 2020-09-18 |
| Tempus Pro Patient Monitor (K201746) | Remote Diagnostic Technologies Limited | 2020-09-18 |
| VX1 (K201298) | Volta Medical | 2020-09-16 |
| UNIFUSE Infusion System with Cooper Wire (K202347) | AngioDynamics, Inc. | 2020-09-15 |
| Athletis PTA Balloon Dilatation Catheter (K201170) | Boston Scientific Corporation | 2020-09-15 |
| AcQMap 3D Imaging and Mapping Catheter (K201341) | Acutus Medical, Inc. | 2020-09-15 |
| VIVO (K200313) | Catheter Precision, Inc. | 2020-09-14 |
| Marathon Flow Directed Micro Catheter (K202318) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-09-14 |
| Feelix Stethoscope (K200862) | Sonavi Labs, Inc. | 2020-09-14 |
| IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 (K192137) | Philips Medizin Systeme Boeblingen GmbH | 2020-09-11 |
| FLEX Vessel Prep System (K202187) | Venturemed Group, Inc. | 2020-09-11 |
| SABER .035 PTA Dilatation Catheter (K201333) | Cordis Corporation | 2020-09-11 |
| HotDog Temperature Management Controller (K201779) | Augustine Temperature Management | 2020-09-11 |
| Fitbit ECG App (K200948) | Fitbit, Inc. | 2020-09-11 |
| Tigereye CTO-Crossing Catheter (K201330) | Avinger, Inc. | 2020-09-10 |
| ClotTriever Thrombectomy System (K193462) | Inari Medical | 2020-09-09 |
| ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), (K202252) | Asahi Intecc Co., Ltd. | 2020-09-08 |
| Astopad Patient Warming System (K202197) | Stihler Electronic GmbH | 2020-09-04 |
| Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (K200212) | Innovative Health, LLC | 2020-09-03 |
| Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 (K202169) | Qura S.R.L | 2020-09-02 |
| VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter (K200812) | Philips Image Guided Therapy Corporation | 2020-09-02 |
| ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (K202182) | Imperative Care, Inc. | 2020-09-02 |
| RX-1 Rhythm Express Remote Cardiac Monitoring System (K200833) | VivaQuant, Inc. | 2020-09-02 |
| Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) (K202251) | Penumbra, Inc. | 2020-08-31 |
| Masimo O3 Regional Oximeter System (K201432) | Masimo Corporation | 2020-08-29 |
| External Counterpulsation System, Soulaire (K202108) | Vamed Medical Instrument Co., Ltd. | 2020-08-28 |
| Infinity M300 (K200859) | Draeger Medical Systems, Inc. | 2020-08-28 |
| Essence 55SP Large Monitor System (K201162) | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2020-08-27 |
| CER-S (K193177) | Cardiocalm | 2020-08-26 |
| Hydrophilic Coating Guide Wire (K193653) | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-08-26 |
| Electronic Blood Pressure Monitor (K200939) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020-08-20 |
| Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 (K193595) | Penumbra, Inc. | 2020-08-19 |