| VariLymph 12 pro (K193476) | Slk Medical GmbH | 2020-08-19 |
| Reusable and Disposable SpO2 Sensors (K201360) | Xinkang Medical Instrument Co. , Ltd. | 2020-08-19 |
| EKOS PE Endovascular Device with Control System 4.0 (CS4.0) (K200648) | Ekos Corporation | 2020-08-17 |
| Route 92 Medical 088 Access System (K201518) | Route 92 Medical | 2020-08-14 |
| Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator (K201916) | Sorin Group Italia S.R.L. | 2020-08-13 |
| Masimo Rad-97 Pulse CO-Oximeter and Accessories (K193626) | Masimo Corporation | 2020-08-10 |
| Sterile High-pressure Angiographic Syringes for Single-use (K192657) | Shenzhen Boon Medical Supply Co., Ltd. | 2020-08-07 |
| Fountain ValveTip Infusion Catheter (K193082) | Merit Medical Systems, Inc. | 2020-08-07 |
| ManaFlow (K200353) | Manamed, Inc. | 2020-08-06 |
| ClariVein IC (K201907) | Merit Medical Systems, Inc. | 2020-08-06 |
| NHancer Rx (K200324) | Imds Operations B.V. | 2020-08-06 |
| Pentaray Nav eco High-Density Mapping Catheter (K201750) | Biosense Webster, Inc. | 2020-08-06 |
| Anchor Dual Lumen Guidewire Catheter (K201076) | Aqure Medical, Inc. | 2020-08-06 |
| Enhanced External Counter Pulsation Device Plus Omay-A (K191955) | Omay(Guangzhou)Med Technologies Co., Ltd. | 2020-08-05 |
| ECG Monitor App (K201168) | Samsung Electronics Co., Ltd. | 2020-08-04 |
| Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter (K192712) | Medtronic, Inc. | 2020-08-03 |
| Arm-Type Fully Automatic Digital Blood Pressure Monitor (K200649) | Joytech Healthcare Co. , Ltd. | 2020-08-03 |
| Carto Octaray Mapping Catheter with Trueref Technology (K193237) | Biosense Webster, Inc. | 2020-07-31 |
| HI-TORQUE PROCEED Guide Wire Family (K201834) | Abbott Vascular | 2020-07-30 |
| Reprocessed NRG Transseptal Needle (K200060) | Innovative Health, LLC | 2020-07-30 |
| Bioflux Software II (K201040) | Biotricity | 2020-07-29 |
| Superpipe Angiographic Catheter (K193647) | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-07-29 |
| Zoom 14 Guidewire (K201760) | Scientia Vascular, LLC | 2020-07-29 |
| Jade (K201794) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-07-28 |
| TRUSELECT Microcatheter (K201792) | Boston Scientific Corporation | 2020-07-28 |
| Tempus LS - Manual (K200849) | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020-07-24 |
| AVVIGO Guidance System (K201713) | Boston Scientific Corporation | 2020-07-23 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K200738) | Microlife Intellectual Property GmbH | 2020-07-23 |
| Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (K201699) | Surgical Instrument and Savings Inc (Dba Medline Renewal) | 2020-07-22 |
| Reprocessed BRK Transseptal Needle (K192998) | Innovative Health, LLC | 2020-07-22 |
| BOBBY Balloon Guide Catheter (K193607) | MicroVention, Inc. | 2020-07-21 |
| Riptide Aspiration System (K201689) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-07-21 |
| Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (K201690) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-07-21 |
| CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (K193380) | Codman & Shurtleff, Inc. | 2020-07-20 |
| GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable (K201179) | Covidien, LLC | 2020-07-20 |
| Arm Blood Pressure Monitor (K193456) | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020-07-16 |
| LifeSignals ECG Remote Monitoring Patch Platform (K200690) | Lifesignals, Inc. | 2020-07-15 |
| EMBOTRAP III Revascularization Device (K193063) | Neuravi, Ltd. | 2020-07-14 |
| AGE Automatic Wrist Blood Pressure Monitor (K193628) | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 |
| Automatic Upper Arm Blood Pressure Monitor (K193627) | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 |
| SmartLinx Vitals Plus Patient Monitoring System (K200856) | Capsule Technologie Sas | 2020-07-10 |
| Automatic Upper Arm Blood Pressure Monitor (K193624) | Dongguan E-Test Technology Co., Ltd. | 2020-07-10 |
| HD Steth (K201299) | Hd Medical, Inc. | 2020-07-10 |
| B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System (K200568) | B&J Manufacturing , Ltd. | 2020-07-10 |
| B&J DVT Compression Devices MHH800/MHH800SQ (K200154) | B&J Manufacturing , Ltd. | 2020-07-08 |
| Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (K200955) | Vascutek, Ltd. | 2020-07-08 |
| CAPERE Thrombectomy System (K201216) | Vascular Medcure, Inc. | 2020-07-08 |
| LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit (K200795) | Medtronic, Inc. | 2020-07-03 |
| Oxxiom (K200537) | True Wearables, Inc. | 2020-07-03 |
| VenaOne (K200285) | Vena Group, LLC | 2020-07-02 |
| Traxcess 7 Mini Guidewire (K201487) | MicroVention, Inc. | 2020-07-02 |
| AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector (K200674) | Atrility Medical, LLC | 2020-07-02 |
| Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer (K193259) | Little Doctor Electronic (Nantong)Co.,Ltd | 2020-07-02 |
| ulrichINJECT CT Motion (K192872) | Ulrich GmbH & Co. KG | 2020-07-02 |
| SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring (K201449) | Medtronic, Inc. | 2020-07-01 |
| LassoStar Circular Mapping Catheter (K193632) | Biosense Webster, Inc. | 2020-06-30 |
| H500 Multi-Sensing Oximetry System (K192900) | Nonin Medical, Inc. | 2020-06-29 |
| Twin-Pass Dual Access Catheter (K193119) | Vascular Solutions, LLC | 2020-06-29 |
| EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System (K201181) | ABBOTT MEDICAL | 2020-06-26 |
| LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US (K193473) | Boston Scientific Corporation | 2020-06-26 |
| EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License (K201148) | ABBOTT MEDICAL | 2020-06-26 |
| Blood Pressure Monitor (K193348) | Shenzhen Viatom Technology Co., Ltd. | 2020-06-25 |
| Blood Pressure Monitor (K200437) | Shenzhen Jamr Technology Co., Ltd. | 2020-06-25 |
| Bendit2.7 Steerable Microcatheter (K200582) | Bend IT Technologies, Ltd. | 2020-06-25 |
| NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (K200195) | Northeast Scientific, Inc. | 2020-06-22 |
| Zeroveno (K192337) | Dimedi Co., Ltd. | 2020-06-22 |
| Patient Monitoring Cable (SpO2 Extension Cable) (K192404) | Shenzhen Coreray Technology, Ltd. | 2020-06-22 |
| MPS 3 Myocardial Protection System (K200438) | Quest Medical, Inc. | 2020-06-19 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K200297) | Microlife Intellectual Property GmbH | 2020-06-18 |
| OptoMonitor 3 (K193620) | Opsens, Inc. | 2020-06-18 |
| Koya Ripple (K193288) | Koya, Inc. | 2020-06-16 |
| Abiomed 23 Fr Sheath (K201116) | Abiomed, Inc. | 2020-06-15 |
| STERIS Patient Warming System (K200446) | STERIS Corporation | 2020-06-13 |
| Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (K193379) | Edwards Lifesciences, LLC | 2020-06-12 |
| Full Automatic(NIBP) Blood Pressure Monitor (K200521) | Health & Life Co., Ltd. | 2020-06-12 |
| ExpanSure Large Access Transseptal Dilator (K201288) | Baylis Medical Company, Inc. | 2020-06-12 |
| INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir (K200683) | Sorin Group Italia S.R.L. | 2020-06-12 |
| physIQ Heart Rhythm and Respiration Module (K193415) | Physiq, Inc. | 2020-06-11 |
| Benchmark BMX96 Access System (K201271) | Penumbra, Inc. | 2020-06-11 |
| ePM Series Patient monitors (K200015) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-06-08 |
| Spire Health Remote Patient Monitoring System (K192952) | Spire, Inc. D/B/A Spire Health | 2020-06-05 |
| Halo™ Single-Loop Snare Kit (K200268) | Argon Medical Devices, Inc. | 2020-06-03 |
| Agilis HisPro Steerable Catheter With Electrodes (K200721) | Abbott (St. Jude Medical) | 2020-06-03 |
| pREBOA-PRO Catheter (K200459) | Prytime Medical Devices, Inc. | 2020-06-03 |
| Vitls Platform (K191620) | Vitls, Inc. | 2020-06-01 |
| UNI*FUSE Infusion System with Cooper Wire (K192864) | AngioDynamics, Inc. | 2020-06-01 |
| iLab Polaris Multi-Modality Guidance System (K201178) | Boston Scientific | 2020-05-29 |
| XO Score Percutaneous Transluminal Angioplasty Scoring Catheter (K193495) | Transit Scientific | 2020-05-29 |
| Automatic Digital Blood Pressure Monitor (K190982) | Xiamen Ants Bro Technology Co., Ltd. | 2020-05-29 |
| Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 (K192981) | Penumbra, Inc. | 2020-05-28 |
| AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (K201112) | Arrow International, Inc. | 2020-05-27 |
| Reconnaissance PV .018 OTW Digital IVUS Catheter (K200410) | Philips Image Guided Therapy Corporation | 2020-05-22 |
| Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface (K201068) | Medtronic, Inc. | 2020-05-21 |
| BeneVision Central Monitoring System (K193391) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-21 |
| Infinity Angioplasty Balloon Catheter (K192399) | Infinity Angioplasty Balloon Company, LLC | 2020-05-20 |
| BP-BT Kiosk (K200287) | Ld Technology, LLC | 2020-05-15 |
| Medtronic Commander Flex (K191745) | Medtronic Care Management Services | 2020-05-15 |
| Support Catheter (K200317) | Qxmedical, LLC | 2020-05-14 |
| Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter (K200700) | Creagh Medical, Ltd. | 2020-05-14 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K201011) | Medtronic, Inc. | 2020-05-13 |