| Abiomed 14Fr Low Profile Introducer Set (K222113) | Abiomed, Inc. | 2022-10-13 |
| Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 (K221857) | Zhejiang Lude Technology Development Co., Ltd. | 2022-10-13 |
| AT-Patch ECG Analysis System (K203638) | Atsens Co., Ltd. | 2022-10-12 |
| Arm Blood Pressure Monitor (K221913) | Alicn Medical Shenzhen, Inc. | 2022-10-12 |
| Branchor Balloon Guide Catheter (K221951) | Asahi Intecc Co., Ltd. | 2022-10-11 |
| InBody Blood pressure monitor, Model BPBIO480KV (K221764) | Inbody Co., Ltd. | 2022-10-07 |
| Pre-Formed Blue (K221575) | Lake Region Medical | 2022-10-07 |
| NuCath Wedge Pressure Catheter (K213666) | Pfm Medical, Inc. | 2022-10-06 |
| A&D Medical UM-212BLE Blood Pressure Monitor (K212168) | A&D Company, Ltd. | 2022-10-06 |
| INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) (K220683) | Penumbra, Inc. | 2022-10-04 |
| Route 92 Medical Full Length 070 Access System (K222743) | Route 92 Medical, Inc. | 2022-10-04 |
| Electronic Sphygmomanometer (Model: LT-P30) (K220220) | Zhuhai Linte Medical Instrument Co., Ltd. | 2022-10-03 |
| Blood Pressure Monitor(Model:Y30001) (K213023) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2022-09-30 |
| MitraClip G4 Steerable Guide Catheter (K221397) | ABBOTT MEDICAL | 2022-09-28 |
| Neteera 130H/131H Vital Sign Monitoring Sensor (K212143) | Neteera Technologies , Ltd. | 2022-09-28 |
| QT ECG (K220795) | QT Medical, Inc. | 2022-09-26 |
| Auryon Atherectomy Catheters (K220116) | Eximo Medical, Ltd. | 2022-09-26 |
| OptiCross™ 18 Peripheral Imaging Catheter (K222568) | Boston Scientific Corporation | 2022-09-23 |
| HotDog Temperature Management System (K220941) | Augustine Temperature Management | 2022-09-23 |
| EpiFaith CV (K212615) | Flat Medical Co., Ltd. | 2022-09-21 |
| Millipede 088 Access Catheter (K214048) | Perfuze, Ltd. | 2022-09-20 |
| LANDMARK REBOA Catheter (K214060) | Zien Medical Technologies, Inc. | 2022-09-19 |
| GEM Biover Microvascular Clamps (K221843) | Synovis Micro Companies Alliance, Inc. | 2022-09-14 |
| SafeSept® Transseptal Guidewire (SS-140) (K221707) | Pressure Products Medical Device Manufacturing, LLC | 2022-09-14 |
| SavvyWire (K213854) | Opsens, Inc. | 2022-09-14 |
| SOFIA 88 Catheter (K214024) | MicroVention, Inc. | 2022-09-12 |
| Easi-Vue embolic microspheres System (K220567) | Abk Biomedical, Inc. | 2022-09-07 |
| ASAHI Gladius Mongo18 PV ES (K213868) | Asahi Intecc Co., Ltd. | 2022-09-06 |
| ROTAPRO Rotational Atherectomy System (K220962) | Boston Scientific Corporation | 2022-09-06 |
| ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter (K221414) | Silk Road Medical, Inc. | 2022-09-02 |
| Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) (K221040) | Jiangxi Aicare Medical Technology Co., Ltd. | 2022-08-31 |
| LimFlow ARC (K221541) | LimFlow, Inc. | 2022-08-31 |
| INDEX BPM (K221486) | Ya Horng Electronic Co., Ltd. | 2022-08-30 |
| Arrow Stiffening Stylet (K220280) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-30 |
| Blood Pressure Monitor (K220676) | Guangdong Transtek Medical Electronics Co., Ltd. | 2022-08-29 |
| Upper Arm Blood Pressure Monitor (K221212) | Shenzhen Yolanda Technology Co., Ltd. | 2022-08-26 |
| LINQ II Insertable Cardiac Monitor (K221962) | Medtronic, Inc. | 2022-08-25 |
| TightRail Guardian Motorized Dilator Sheath (K212784) | Spectranetics, Inc. | 2022-08-24 |
| Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter (K221528) | Edwards Lifesciences, LLC | 2022-08-22 |
| SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter (K221832) | Cordis US Corp | 2022-08-22 |
| Stent Positioning Assistance System (SPAS) (K221917) | Seven Sons , Ltd. | 2022-08-19 |
| GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) (K220647) | Vascular Solutions, LLC | 2022-08-18 |
| EnSite X EP System (K221213) | Abbott | 2022-08-18 |
| Benchmark BMX96 Access System (K213390) | Penumbra, Inc. | 2022-08-18 |
| Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS (K221353) | Qura S.R.L | 2022-08-18 |
| CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) (K221112) | Biosense Webster, Inc. | 2022-08-17 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (K221852) | Shockwave Medical, Inc. | 2022-08-16 |
| YUWELL Finger Pulse Oximeter (K212385) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2022-08-16 |
| HeRO Graft (K213845) | Merit Medical Systems, Inc. | 2022-08-15 |
| Patient Monitor: RespArray (K220308) | Edan Instruments, Inc. | 2022-08-11 |
| Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 (K221879) | Caf Medical Solutions, Inc. | 2022-08-10 |
| LimFlow V-Ceiver (K222083) | LimFlow, Inc. | 2022-08-09 |
| Reprocesses Umbilical Cable (K221854) | Innovative Health, LLC | 2022-08-06 |
| Mini-ClotTriever Thrombectomy System (K220887) | Inari Medical | 2022-08-04 |
| exGraft, exGraft Carbon (K221628) | Peca Labs | 2022-08-04 |
| Masimo CARESCAPE SpO2 – Masimo with SpHb (K221953) | Masimo Corporation | 2022-08-04 |
| QOCA Portable ECG Monitoring Device (K210179) | Quanta Computer, Inc. | 2022-08-02 |
| Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 (K221616) | Caf Medical Solutions, Inc. | 2022-08-01 |
| Next Generation NetKonnect (K220989) | Nihon Kohden Digital Health Solutions, Inc. | 2022-07-29 |
| 091 Balloon Guide Catheter (K220331) | Inneuroco, Inc. | 2022-07-29 |
| Bodyport Cardiac Scale (K211585) | Bodyport, Inc. | 2022-07-29 |
| Catapult Guide Sheath (K221914) | Contract Medical International, GmbH | 2022-07-29 |
| Biotres (K222017) | Biotricity | 2022-07-28 |
| DeepRhythmAI (K210822) | Medicalgorithmics S.A. | 2022-07-27 |
| BIOMONITOR IIIm, BIOMONITOR III (K221856) | Biotronik, Inc. | 2022-07-27 |
| Upper Arm Type Blood Pressure Monitor (K220886) | Shenzhen Jamr Technology Co., Ltd. | 2022-07-27 |
| CorPath GRX System (K221464) | Corindus, Inc. | 2022-07-27 |
| Tigertriever 13 Revascularization Device (K220808) | Rapid Medical Ltd. | 2022-07-25 |
| MedWand (K212975) | Medwand Solutions, Inc. | 2022-07-22 |
| ZEUS System (Zio Watch) (K213409) | iRhythm Technologies, Inc. | 2022-07-19 |
| Selectra Lead Implantation System (K222037) | Biotronik, Inc. | 2022-07-19 |
| MAGIC Flow-Dependent Microcatheter (K213435) | Balt USA, LLC | 2022-07-19 |
| Tiche PTA Balloon Dilatation Catheter (K212215) | Brosmed Medical Co., Ltd. | 2022-07-19 |
| Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor (K213357) | Verily Life Sciences, LLC | 2022-07-19 |
| ers2 - ergoline Rehabilitation System (K212883) | Ergoline GmbH | 2022-07-15 |
| AHI System (K221203) | Fifth Eye, Inc. | 2022-07-14 |
| Protrieve Sheath (K220415) | Inari Medical, Inc. | 2022-07-12 |
| N Series Patient Monitors (K213799) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-07-12 |
| Artix Ballon Guiding Sheath (K221846) | Inari Medical | 2022-07-11 |
| medi pneumatic compression system (pcs)-genius (Model 652) (K221654) | Medi USA, LP | 2022-07-07 |
| Oscar Peripheral Multifunctional Catheter system (K214038) | Biotronik, Inc. | 2022-07-06 |
| NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter (K220171) | Northeast Scientific, Inc. | 2022-07-01 |
| GEM (K213385) | Obsidio, Inc. | 2022-07-01 |
| AcQMap High Resolution Imaging and Mapping System (K220784) | Acutus Medical, Inc. | 2022-07-01 |
| CROSSLEAD Peripheral Guide Wire (K213315) | Asahi Intecc Co., Ltd. | 2022-07-01 |
| NC TREK NEO Coronary Dilatation Catheter (K220634) | Abbott Vascular | 2022-06-30 |
| Wrist Type Blood Pressure Monitor (K220651) | Shenzhen Jamr Medical Technology Co., Ltd. | 2022-06-30 |
| Epicardial Access System (K213582) | Baylis Medical Company, Inc. | 2022-06-30 |
| VASSALLO GT 018 Floppy (K213949) | Filmecc Co., Ltd. | 2022-06-30 |
| CPS AIM Universal II Slittable Inner Catheter (K221750) | ABBOTT MEDICAL | 2022-06-30 |
| RADIFOCUS Torque Device (K220934) | Terumo Medical Products (Hangzhou) Co., Ltd. | 2022-06-29 |
| Eko Murmur Analysis Software (EMAS) (K213794) | Eko Devices, Inc. | 2022-06-29 |
| DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) (K220544) | Ra Medical Systems,Inc | 2022-06-29 |
| Ebony HP PTA OTW 0.035 Catheter (K220410) | Natec Medical , Ltd. | 2022-06-29 |
| Med-link Disposable ECG Cable and Leadwires (K220447) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2022-06-28 |
| VenAir, Sequential Compression System (K213577) | Apex Medical Corp. | 2022-06-28 |
| EZYPRO ECG Recorder (Model: UG02) (K213233) | Sigknow Biomedical Co., Ltd. | 2022-06-23 |
| Excipio SV Thrombectomy Device (K221204) | Contego Medical, Inc. | 2022-06-23 |
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (K213682) | Edwards Lifesciences, LLC | 2022-06-22 |
| T3 Platform Software (K213230) | Etiometry, Inc. | 2022-06-22 |