| ClotTriever Thrombectomy System (K221531) | Inari Medical, Inc. | 2023-02-06 |
| Care Team Portal (K222398) | Vivify Health, Inc. | 2023-02-06 |
| 14F iSLEEVE™ Introducer Set (K230051) | Boston Scientific Corporation | 2023-02-03 |
| IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) (K221348) | Philips Medizin Systeme Böblingen GmbH | 2023-02-03 |
| Anivia SG1000 Pump Console (K221491) | Apmtd, Inc. | 2023-02-03 |
| NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (K223026) | Northeast Scientific, Inc. | 2023-02-03 |
| Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) (K222153) | Microlife Intellectual Property GmbH | 2023-02-03 |
| Aristotle Colossus Guidewire (K222437) | Scientia Vascular, Inc. | 2023-01-26 |
| VX1+ (K223516) | Volta Medical | 2023-01-21 |
| Highlander™ 014 PTA Balloon Dilatation Catheter (K223177) | C.R. Bard, Inc. | 2023-01-20 |
| Capiflo 5001 (K222158) | K&L Distributing, Inc. | 2023-01-20 |
| Medaica M1 Telehealth Stethoscope (K223166) | Medaica, Inc. | 2023-01-19 |
| Low Profile Companion Sheath (K223872) | Merit Medical Systems, Inc. | 2023-01-19 |
| Tunnel Crossing Catheter (K221163) | Tractus Vascular, LLC | 2023-01-19 |
| Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console (K223746) | Zoll Circulation, Inc. | 2023-01-13 |
| Garmin ECG App (K221774) | Garmin International, Inc. | 2023-01-12 |
| Artix BG (K223000) | Inari Medical | 2023-01-11 |
| ISAAC Neurovascular Navigation Catheter (K222115) | MicroVention, Inc. | 2023-01-10 |
| T3 Platform software (K213423) | Etiometry, Inc. | 2023-01-06 |
| CSF-3 (K221260) | Cardiacsense | 2023-01-06 |
| Radial Artery Compression Tourniquets (K222182) | Beijing Demax Medical Technology Co.,Ltd | 2023-01-04 |
| Biobeat Platform-2 and BB-613WP Patch (K222010) | Biobeat Technologies , Ltd. | 2022-12-30 |
| EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (K210313) | Shanghai Microport EP Medtech Co., Ltd. | 2022-12-30 |
| Fingertip Pulse Oximeter (K213430) | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2022-12-30 |
| Multi-Parameter Patient Monitor (K211619) | Shenzhen Comen Medical Instruments Co.,Ltd | 2022-12-29 |
| EndoPATx (K211557) | Itamar Medical , Ltd. | 2022-12-29 |
| EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License (K223094) | ABBOTT MEDICAL | 2022-12-27 |
| IOB Warming Blankets (K221669) | Iob Medical, Inc. | 2022-12-27 |
| TruWave Disposable Pressure Transducer (K222216) | Edwards Lifesciences, LLC | 2022-12-22 |
| NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (K222538) | Sino Medical Sciences Technology, Inc. | 2022-12-21 |
| LimFlow Vector (K221902) | LimFlow, Inc. | 2022-12-21 |
| Mural Clinical Viewer (K222586) | Ge Medical Systems Information Technologies, Inc. | 2022-12-21 |
| AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) (K223050) | MicroVention, Inc. | 2022-12-21 |
| Indigo Aspiration System - Lightning Flash (K222358) | Penumbra, Inc. | 2022-12-20 |
| EK12 V2 Algorithm (K221904) | Ge Medical Systems Information Technologies, Inc. | 2022-12-20 |
| Penumbra System (Reperfusion Catheter RED 43) (K222808) | Penumbra, Inc. | 2022-12-20 |
| Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) (K222213) | Unimed Medical Supplies, Inc. | 2022-12-19 |
| Mechanical Guidewire (K221351) | Baylis Medical Company, Inc. | 2022-12-19 |
| ViewFlex Xtra Reprocessed ICE Catheter (K222217) | ABBOTT MEDICAL | 2022-12-19 |
| INOUE BALLOON A (K220881) | Toray Industries, Inc. | 2022-12-18 |
| Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) (K213984) | Shenzhen Zhengkang Technology Co., Ltd. | 2022-12-16 |
| VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor (K221267) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-12-15 |
| TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) (K223472) | Spectranetics, Inc. | 2022-12-15 |
| PTA Balloon Dilatation Catheter (K221245) | Kossel Medtech (Suzhou) Co., Ltd. | 2022-12-14 |
| BioButton System (K212957) | Biolntellisense, Inc. | 2022-12-12 |
| AIROS 6P Sequential Compression Device (K223195) | Airos Medical, Inc. | 2022-12-09 |
| Swang-Ganz IQ pulmonary artery catheter (K222117) | Edwards Lifesiences, LLC | 2022-12-09 |
| CELLO II Balloon Guide Catheter (K223275) | Fuji Systems Corporation | 2022-12-09 |
| AIROS 8P Sequential Compression Device (K223193) | Airos Medical, Inc. | 2022-12-09 |
| FloPatch FP120 (K222242) | Flosonics Medical | 2022-12-09 |
| CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (K222038) | Abbott (Formerly Thoratec Corporation) | 2022-12-08 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K222837) | Spectranetics, Inc. | 2022-12-08 |
| ViewFlex Xtra ICE Catheter (K223077) | Irvine Biomedical, A St. Jude Medical Company | 2022-12-07 |
| Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (K222019) | Stryker Sustainability Solutions | 2022-12-04 |
| Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor (K221113) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-12-02 |
| PageWriter TC35 Cardiograph (K221141) | Medizin Systeme Boblingen GmbH | 2022-12-02 |
| STAR Apollo Mapping System (K220786) | Rhythm Al, Ltd. | 2022-12-01 |
| Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G (K222125) | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-12-01 |
| CentriMag Pre-connected Pack (K222297) | Abbott | 2022-12-01 |
| pNOVUS 21 Microcatheter (K221279) | Phenox, Ltd. | 2022-11-28 |
| Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer (K222652) | Cardicare Company, Ltd. | 2022-11-28 |
| EchoGo Heart Failure (K222463) | Ultromics Limited | 2022-11-23 |
| HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) (K221704) | Edwards Lifesciences, LLC | 2022-11-22 |
| ANNE Pediatric (K221530) | Sibel, Inc. | 2022-11-22 |
| GUS610 Blood pressure monitor (K222160) | Globalcare Medical Technology Co., Ltd. | 2022-11-22 |
| Disposable Blood Pressure Cuff (K222420) | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022-11-21 |
| Empatica Health Monitoring Platform (K221282) | Empatica S.r.l. | 2022-11-20 |
| Polso Watch (K220351) | Chronisense Medical, Ltd. | 2022-11-18 |
| Heater-Cooler System 3T (K220635) | Livanova Deutschland, GmbH | 2022-11-16 |
| Cardio10 (K220535) | Bionet Co., Ltd. | 2022-11-15 |
| LifeSPARC System (K211830) | Cardiacassist, Inc. | 2022-11-15 |
| Multiflex Steerable Sheath (K221655) | Vizaramed, Inc. | 2022-11-14 |
| WOLF Thrombectomy™ SmartClaw Catheter (K221391) | Devoro Medical, Inc. | 2022-11-10 |
| SelectSite C304 Deflectable Catheter System, C315 Delivery System (K223178) | Medtronic | 2022-11-08 |
| Oxyfit Pulse Oximeter (K203812) | Shenzhen Viatom Technology Co., Ltd. | 2022-11-08 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module (K221833) | Edwards Lifesciences, LLC | 2022-11-07 |
| Vericor Support Catheter (K222679) | Vascupatent Medical (Shenzhen) Co., Ltd. | 2022-11-07 |
| Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system (K222873) | Medtronic | 2022-11-07 |
| Eclipse MINI Model 98900 (K212317) | Spacelabs Healthcare, Ltd. | 2022-11-07 |
| HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable (K223127) | Edwards Lifeciences, LLC | 2022-11-07 |
| BENCHMARK BMX81 Access System (K221822) | Penumbra, Inc. | 2022-11-04 |
| ibiomedi Electronic Stethoscope ES-2020 (K220466) | Sound Land Corp. | 2022-11-03 |
| Current Health System (K222550) | Current Health , Ltd. | 2022-11-01 |
| Welch Allyn Connex Central Station (K212473) | Welch Allyn, Inc. | 2022-10-28 |
| VASSALLO GT EXT (K222631) | Filmecc Co., Ltd. | 2022-10-26 |
| KODEX – EPD™ System 1.5.0 (K212493) | Philips Medical Systems Nederland, B.V. (Pmsn) | 2022-10-24 |
| eWave Monitor (K214073) | Wearlinq, Inc. | 2022-10-20 |
| PADnet Xpress (K220527) | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022-10-20 |
| eClinic Stethopod (K220099) | Homediagnostic, LLC | 2022-10-20 |
| Houdini Cross Support Catheter (K213466) | Cruzar Medsystems, Inc. | 2022-10-20 |
| V-Patch Cardiac Monitor (K222842) | Shandong Corecare Technology Limited | 2022-10-20 |
| Vascu-Guard Vascular Repair Patch (K221032) | Synovis Life Technologies, Inc. | 2022-10-19 |
| PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (K221029) | Synovis Life Technologies, Inc. | 2022-10-19 |
| MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System (K221321) | Ge Medical Systems Information Technologies, Inc. | 2022-10-18 |
| XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter (K221986) | Transit Scientific, LLC | 2022-10-18 |
| YUWELL Electronic Blood Pressure Monitor (K221372) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2022-10-17 |
| AcQMap High Resolution Imaging and Mapping System (K222209) | Acutus Medical, Inc. | 2022-10-17 |
| Pulse Oximeter (Model C101A2, C101B1, C101A3) (K221979) | Shenzhen Imdk Medical Technology Co., Ltd. | 2022-10-16 |
| HeartFlow Analysis (K213857) | HeartFlow, Inc. | 2022-10-14 |
| Sublime Microcatheter (K221886) | Surmodics,Inc. | 2022-10-14 |