| Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) (K212665) | Huizhou Xiaoou Technology Co., Ltd. | 2022-06-22 |
| Aspirex Thrombectomy System (K220270) | C.R. Bard, Inc. | 2022-06-21 |
| AcQMap 3D Imaging and Mapping Catheter, Model 900009 (K210766) | Acutus Medical, Inc. | 2022-06-21 |
| Langston dual lumen catheter (K221470) | Vascular Solutions, LLC | 2022-06-17 |
| CipherOx CRI Tablet (K213255) | Flashback Technologies, Inc. | 2022-06-17 |
| QardioArm 2 (K220106) | Qardio, Inc. | 2022-06-15 |
| Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2022-06-12 |
| Extroducer Infusion Catheter System (K213442) | SmartWise Sweden AB | 2022-06-10 |
| WesperO2 (K213515) | Wesper, Inc. | 2022-06-10 |
| IntellaMap Orion High Resolution Mapping Catheter (K220796) | Boston Scientific Corporation | 2022-06-10 |
| Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection (K221339) | Contego Medical, Inc. | 2022-06-09 |
| Auryon Atherectomy System (K221077) | Eximo Medical, Ltd. | 2022-06-09 |
| Infinity Gateway Suite (K203579) | Draeger Medical Systems, Inc. | 2022-06-07 |
| eCareManager 4.5 (K211046) | Visicu, Inc. | 2022-06-03 |
| Atrial Fibrillation History Feature (K213971) | Apple, Inc. | 2022-06-03 |
| CIRCUL8 Connect DVT Prevention Device (K220761) | Ortho8, Inc. | 2022-06-03 |
| Minjie Catheter System (K212288) | Kai Medtech, LLC | 2022-06-02 |
| Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console (K220008) | Zoll Circulation, Inc. | 2022-06-02 |
| Q Patch (K210758) | Medicalgorithmics S.A. | 2022-06-02 |
| Boss Crossing Support Catheter (K220632) | Marvao Medical Devices, Ltd. | 2022-06-02 |
| BeneVision Central Monitoring System (K220058) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-06-01 |
| eMurmur Heart AI (K220766) | Csd Labs GmbH | 2022-05-31 |
| Distal Access Catheter (K213065) | Guangzhou Easycess Medical Co.,Ltd | 2022-05-31 |
| Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) (K220113) | Shenzhen Finicare Co., Ltd. | 2022-05-31 |
| Liverty™ TIPS Access Set (K221440) | Bard Peripheral Vascular, Inc. | 2022-05-31 |
| FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT (K212268) | FMD Co., Ltd. | 2022-05-27 |
| MoistureMeterD Compact, LymphScanner (K220557) | Delfin Technologies, Ltd. | 2022-05-27 |
| Benchmark Intracranial Access System (K212838) | Penumbra, Inc. | 2022-05-27 |
| ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. (K211779) | Chip Ideas Electronics S.L. | 2022-05-26 |
| KardiaMobile 6L (K220350) | AliveCor, Inc. | 2022-05-25 |
| Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (K210655) | Innovative Health, LLC | 2022-05-25 |
| Smart Wireless Stethoscope (K220470) | Shanghai Hulu Devices Co., Ltd. | 2022-05-23 |
| Triever24, Triever20 (K213402) | Inari Medical | 2022-05-23 |
| ONO Retrieval Device (K212988) | Onocor Vascular, LLC | 2022-05-23 |
| Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set (K213540) | Qura S.R.L | 2022-05-20 |
| Med-link Pulse Oximeter (K212752) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2022-05-20 |
| WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 (K212416) | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022-05-18 |
| Medline Integrated Arterial Catheter (K210548) | Centurion Medical Products | 2022-05-17 |
| Imperative Care Radial 088 Access System (K220807) | Imperative Care, Inc. | 2022-05-17 |
| VersaCross Connect Transseptal Dilator (K220414) | Baylis Medical Company, Inc. | 2022-05-09 |
| Masimo O3 Regional Oximeter System (K214072) | Masimo Corporation | 2022-05-06 |
| Quantum Heater-Cooler (K212657) | Spectrum Medical , Ltd. | 2022-05-06 |
| Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC (K212555) | Covidien, LLC | 2022-05-06 |
| Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger (K220110) | Qura S.R.L | 2022-05-06 |
| AcQGuide® VUE Steerable Sheath (K221044) | Acutus Medical, Inc. | 2022-05-05 |
| Viatrac 14 Plus Peripheral Dilatation Catheter (K221057) | Abbott Vascular | 2022-05-05 |
| Spartan SC 069 (K220716) | Spartan Micro, Inc. | 2022-05-05 |
| LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension (K220691) | Seigla Medical, Inc. | 2022-05-05 |
| LiveOne (K201302) | Livemetric (Medical) S.A. | 2022-05-04 |
| Serranator PTA Serration Balloon Catheter (K220704) | Cagent Vascular, LLC | 2022-05-04 |
| Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter (K212588) | C.R. Bard, Inc. | 2022-05-04 |
| ECGenius System (K220306) | Cath Vision Aps | 2022-05-03 |
| Intra.Ox 2.0 Handheld Tissue Oximeter (K221010) | Vioptix, Inc. | 2022-05-03 |
| Ultiri Measurement System (K220243) | ABBOTT MEDICAL | 2022-04-30 |
| Oxehealth Vital Signs (K220899) | Oxehealth Limited | 2022-04-29 |
| LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) (K220383) | Okami Medical | 2022-04-29 |
| Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K220568) | Cardiovascualr Systems, Inc. | 2022-04-27 |
| EXTesia Introducer Sheath Set (K220604) | Curatia Medical Co. | 2022-04-27 |
| Strados Remote Electronic Stethoscope Platform (RESP) (K220893) | Strados Labs, Inc. | 2022-04-27 |
| AliveCor QT Service (K212662) | AliveCor, Inc. | 2022-04-26 |
| CER-S (K213861) | Cardiocalm Srl | 2022-04-25 |
| Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System (K221041) | Shockwave Medical, Inc. | 2022-04-25 |
| MESI mTABLET TBI diagnostic system, MESI mTABLET TBI (K213730) | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2022-04-21 |
| EKOS+ Endovascular Device (K220866) | Boston Scientific | 2022-04-20 |
| GEM FLOW COUPLER Monitor (GEM1020M-2) (K213974) | Synovis Micro Companies Alliance, Inc. | 2022-04-20 |
| Spartan Center Wire (K220075) | Spartan Micro, Inc. | 2022-04-19 |
| Coala Heart Monitor (K212163) | Coala Life AB | 2022-04-14 |
| Amputee Garment for use with Lympha Press Optimal Plus (K214053) | Mego Afek AC , Ltd. | 2022-04-14 |
| CARESCAPE B450, E-musb (K213363) | GE Healthcare Finland Oy | 2022-04-13 |
| Carescape B850, E-musb (K213336) | GE Healthcare Finland Oy | 2022-04-13 |
| Bendit21 Microcatheter (K203842) | Bend IT Technologies, Ltd. | 2022-04-13 |
| CARESCAPE B650, E-musb (K213181) | GE Healthcare Finland Oy | 2022-04-13 |
| Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) (K220773) | Medtronic Vascular | 2022-04-13 |
| EMBOLD Fibered Detachable Coil System (K213398) | Boston Scientific Corporation | 2022-04-12 |
| CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 (K213234) | Ge Medical Systems Information Technologies, Inc. | 2022-04-12 |
| PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter (K214025) | Medos International SARL | 2022-04-12 |
| XO CROSS CORONARY Support Catheter (K214107) | Transit Scientific, LLC | 2022-04-11 |
| Micro Catheter and Guidewire System (K212719) | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2022-04-11 |
| Fitbit Irregular Rhythm Notifications (K212372) | Fitbit, Inc. | 2022-04-08 |
| Prestige Coil System (K220699) | Bait USA, LLC | 2022-04-08 |
| Electrocardiograph (K212278) | Edan Instruments, Inc. | 2022-04-07 |
| ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire (K220654) | Cordis Corporation | 2022-04-06 |
| Prodigy Thrombectomy System (K214114) | Truvic Medical, Inc. | 2022-04-06 |
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (K213388) | AngioDynamics, Inc. | 2022-04-04 |
| Aveir Retrieval Catheter (K213494) | ABBOTT MEDICAL | 2022-04-01 |
| Intri24 Sheath (K212392) | Inari Medical, Inc. | 2022-04-01 |
| Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (K213490) | Ge Medical Systems Information Technologies, Inc. | 2022-04-01 |
| DEEPVESSEL FFR (K213657) | Keyamed Na, Inc. | 2022-04-01 |
| PhasTIPP (K212894) | LeMaitre Vascular, Inc. | 2022-03-31 |
| ERIC Retrieval Device (K211120) | MicroVention, Inc. | 2022-03-31 |
| CareTaker Monitor App (K213699) | Caretaker Medical, LLC | 2022-03-30 |
| Biobeat Platform, BB-613WP Patch (K212153) | Biobeat Technologies , Ltd. | 2022-03-25 |
| Artix Thrombectomy Device (K220600) | Inari Medical | 2022-03-25 |
| LE-12CH (K220362) | Caf Medical Solutions, Inc. | 2022-03-25 |
| Emerge Monorail PTCA Dilatation Catheter (K220629) | Boston Scientific | 2022-03-24 |
| Steth IO Spot (K220196) | Stratoscientific | 2022-03-24 |
| Alio Medical Remote Monitoring System (K211365) | Graftworx, Inc. Dba Alio | 2022-03-24 |
| Dib UltraNav Transseptal Catheter System (K213492) | Dib Ultranav Medical, LLC | 2022-03-24 |
| FUBUKI XF Neurovascular Long Sheath (K213589) | Asahi Intecc Co., Ltd. | 2022-03-24 |
| PathBuilder Transseptal Needle (K212625) | Shanghai Microport EP Medtech Co., Ltd. | 2022-03-23 |