| Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211875) | William Cook Europe Aps | 2021-07-28 |
| Rist 071 Radial Access Guide Catheter (K211990) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-27 |
| Aveir Introducer (K211989) | ABBOTT MEDICAL | 2021-07-27 |
| DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) (K210664) | Ra Medical Systems,Inc | 2021-07-27 |
| doctorgram Stethoscope DES-I (K210736) | Gv Concepts | 2021-07-27 |
| Route 92 Medical Full Length 088 Access System (K210635) | Route 92 Medical, Inc. | 2021-07-27 |
| VS Newborn Heart Rate Monitor (K201887) | Surepulse Medical Limited | 2021-07-23 |
| CardioCurve Steerable Sheath (K210185) | Talon Surgical | 2021-07-23 |
| Reveal LINQ Insertable Cardiac Monitor (K212008) | Medtronic, Inc. | 2021-07-22 |
| LifeSignals Multi-Parameter Remote Monitoring Platform (K202868) | Lifesignals, Inc. | 2021-07-21 |
| LifeLens Wireless ECG Monitor (K203168) | LifeLens Technologies, Inc. | 2021-07-20 |
| Vital Signs (K211906) | Oxehealth Limited | 2021-07-20 |
| Z-6 Atrioseptostomy Catheter (K211910) | NuMED, Inc. | 2021-07-19 |
| SwiftNINJA Steerable Microcatheter (K211525) | Merit Medical Systems, Inc. | 2021-07-16 |
| Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System (K203435) | Nihon Kohden Corporation | 2021-07-16 |
| Bio-Medicus Life Support Catheter and Introducer (K201100) | Medtronic, Inc. | 2021-07-15 |
| ReCross (K210431) | Imds Operations B.V. | 2021-07-15 |
| EOS PMP (K211495) | Sorin Group Italia S.R.L. | 2021-07-12 |
| Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables (K203556) | Medtronic, Inc. | 2021-07-12 |
| Tamarin Blue PTCA RX Dilatation Catheter (K210012) | Natec Medical , Ltd. | 2021-07-09 |
| AortaSTAT Occlusion Device (K210602) | Renalpro Medical, Inc. | 2021-07-09 |
| HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform (K211465) | Edwards Lfesciences | 2021-07-08 |
| Arterial Catheter (K201726) | Haolang Medical USA Corporation | 2021-07-07 |
| SafeCross Transseptal Puncture and Introducer (TSP/I) System (K203459) | East End Medical I, LLC | 2021-07-06 |
| Selethru(TM) NC PTCA Balloon Dilatation Catheter (K211393) | Kossel Medtech (Suzhou) Co., Ltd. | 2021-07-02 |
| Penumbra System (RED 68 Reperfusion Catheter) (K211411) | Penumbra, Inc. | 2021-07-01 |
| Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph (K210560) | Philips Medical Systems | 2021-06-30 |
| Quantum Perfusion Arterial Cannula Graft (K203057) | Qura S.R.L | 2021-06-30 |
| KardiaMobile 6L (K210753) | AliveCor, Inc. | 2021-06-30 |
| iLab Polaris Multi-Modality Guidance System (K210889) | Boston Scientific Corporation | 2021-06-25 |
| Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K201806) | Sterilmed Inc. (Johnson and Johnson) | 2021-06-23 |
| Sublime Radial Access 018 RX Dilatation Catheter (K211044) | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, | 2021-06-16 |
| 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System (K211518) | Volcano Atheromed, Inc. | 2021-06-14 |
| LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System (K210484) | Medtronic, Inc. | 2021-06-11 |
| BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) (K211061) | Thrombolex, Inc. | 2021-06-10 |
| ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing (K211476) | Imperative Care, Inc. | 2021-06-08 |
| HRVWatch-Mini Wrist Monitor (K201914) | Taiwan Scientific Corporation | 2021-06-07 |
| AlphaVac Multipurpose Mechanical Aspiration (MMA) System (K211081) | AngioDynamics, Inc. | 2021-06-04 |
| PCA-C1 series Patient Cable (K200722) | QT Medical, Inc. | 2021-06-03 |
| Breezeway II (K210627) | Oscor, Inc. | 2021-06-03 |
| LINQ II Insertable Cardiac Monitor (K211304) | Medtronic, Inc. | 2021-05-28 |
| coraCross (K210188) | Reflow Medical | 2021-05-28 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (K203687) | Edwards Lifesciences, LLC | 2021-05-28 |
| BIB Stent Placement Catheter (K211134) | NuMED, Inc. | 2021-05-27 |
| PlasmaWave (K211253) | Manamed, Inc. | 2021-05-26 |
| ViperCath XC Peripheral Exchange Catheter (K211251) | Cardiovascular Systems, Inc. | 2021-05-26 |
| HeRO Graft, HeRO Adapter (K203724) | Merit Medical Systems, Inc. | 2021-05-25 |
| LUX-Dx Insertable Cardiac Monitor (K210608) | Boston Scientific Corporation | 2021-05-25 |
| Neurescue device (K210358) | Neurescue Aps | 2021-05-21 |
| Zio ECG Utilization Software (ZEUS) System (K202527) | iRhythm Technologies, Inc. | 2021-05-21 |
| Zio Monitor (K202359) | iRhythm Technologies, Inc. | 2021-05-21 |
| Penumbra System (Reperfusion Catheter RED 62) (K203440) | Penumbra, Inc. | 2021-05-20 |
| Vitals360 Multi-Vitals Mobile Monitor (K210086) | Vocare, Inc. | 2021-05-20 |
| Cardiac Trigger Monitor (K202138) | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL (K210417) | Bio Compression Systems, Inc. | 2021-05-14 |
| AcQGuide MAX Steerable Sheath (K211100) | Acutus Medical, Inc. | 2021-05-14 |
| ClotTriever Thrombectomy System (K210689) | Inari Medical, Inc. | 2021-05-12 |
| Automatic Arm Electronic Blood Pressure Monitor (K210435) | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021-05-12 |
| Reprocessed Tri Pulse Compression Garment (K203847) | Renu Medical, Inc. | 2021-05-07 |
| KardiFlex NC Coronary Dilatation Catheter (K202578) | Medcaptain Life Science Co., Ltd. | 2021-05-06 |
| Quantum Mini Ventilation Module (K210669) | Spectrum Medical , Ltd. | 2021-05-04 |
| Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (K203655) | Innovative Health, LLC | 2021-05-04 |
| VASSALLO GT Hybrid (K203529) | Filmecc Co., Ltd. | 2021-05-04 |
| MC3 Crescent Jugular Dual Lumen Catheter (K203409) | Mc3, Inc. | 2021-05-03 |
| SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter (K210647) | Vascular Solutions, LLC | 2021-04-30 |
| MAC 7 - Resting ECG Analysis System (K203786) | Ge Medical Systems Information Technologies, Inc. | 2021-04-30 |
| FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 (K211013) | Inari Medical, Inc. | 2021-04-30 |
| KardiFlex PTCA Balloon Dilatation Catheter (K202619) | Medcaptain Life Science Co., Ltd. | 2021-04-29 |
| 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation (K210605) | 3M Company | 2021-04-29 |
| Plato 17 Microcatheter (K210601) | Scientia Vascular, LLC | 2021-04-28 |
| CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor (K202757) | Contec Medical Systems Co.,Ltd | 2021-04-28 |
| Vital Sign Monitoring Sensor (Model :XK300) (K202464) | Xandar Kardian, Inc. | 2021-04-26 |
| Dayspring (K210885) | Koya Medical, Inc. | 2021-04-23 |
| SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K210626) | Cordis Corporation | 2021-04-23 |
| Pulse Oximeter (K203854) | Shenzhen Hexin Zondan Medical Equipment Co., Ltd. | 2021-04-23 |
| ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (K210996) | Imperative Care, Inc. | 2021-04-23 |
| DVT-PRO (K203353) | Daesung Maref Co., Ltd. | 2021-04-22 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter (K203365) | Shockwave Medical, Inc. | 2021-04-22 |
| VASSALLO GT (K203533) | Filmecc Co., Ltd. | 2021-04-21 |
| SoundBite Crossing System - Peripheral (14P) (K210839) | Soundbite Medical Solutions, Inc. | 2021-04-20 |
| SOZO (K203473) | ImpediMed Limited | 2021-04-19 |
| Verrata PLUS Pressure Guide Wire (K210235) | Volcano Corporation | 2021-04-15 |
| Instylla Microcatheter 1.2 (K210808) | Instylla, Inc. | 2021-04-15 |
| Artimes pro Balloon Dilatation Catheter (K203390) | Brosmed Medical Co., Ltd. | 2021-04-14 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K202729) | Microlife Intellectual Property GmbH | 2021-04-08 |
| Endovascular Dilator and Sets (K210734) | Cook Incorporated | 2021-04-06 |
| Vascutek Gelsoft Plus ERS Vascular Graft (K202703) | Vascutek, Ltd. | 2021-04-06 |
| SiteSeal SV (K210681) | Ensite Vascular | 2021-04-06 |
| AcQCross Qx Integrated Transseptal Dilator/Needle (K210685) | Acutus Medical, Inc. | 2021-04-06 |
| Stockert S5 System (K210130) | Livanova Deutschland, GmbH | 2021-04-05 |
| SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System (K203310) | Jiangsu Synecoun Medical Technology Co., Ltd. | 2021-04-02 |
| B-Capta (K202154) | Livanova Deutschland, GmbH | 2021-04-01 |
| Omron Model BP7900 Blood Pressure Monitor + EKG (K202228) | Omron Healthcare, Inc. | 2021-04-01 |
| AMG PMP Pediatric (K202206) | Eurosets S.R.L | 2021-04-01 |
| Gili Pro BioSensor (also known as “Gili BioSensor System”) (DEN200038) | Continuse Biometrics , Ltd. | 2021-04-01 |
| Guidion (K210110) | Imds Operations B.V. | 2021-03-31 |
| 3M Bair Hugger Temperature Management System (Model 675) (K210603) | 3M Company | 2021-03-30 |
| DVT-4000S (K203417) | Daesung Maref Co., Ltd. | 2021-03-28 |
| Oxehealth Vital Signs (DEN200019) | Oxehealth Limited | 2021-03-26 |
| TandemHeart Pump and Escort Controller (K202751) | Cardiacassist, Inc. | 2021-03-26 |