| ArteVu (K244007) | Cardio Ring Technologies, Inc. Taiwan Branch | 2025-07-30 |
| EnSite™ X EP System (K251234) | ABBOTT MEDICAL | 2025-07-30 |
| Micro Catheter (K243534) | Suzhou Zenith Vascular SciTech Limited | 2025-07-30 |
| MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (K250356) | Infobionic, Inc. | 2025-07-29 |
| Sleepiz One+ (2.5) (K251364) | Sleepiz AG | 2025-07-29 |
| Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (K250179) | Edan Instruments, Inc. | 2025-07-29 |
| ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (K250652) | Anumana, Inc. | 2025-07-28 |
| TransForm McCarthy Mitral Annuloplasty Ring (TF) (K250859) | Genesee Biomedical, Inc. | 2025-07-25 |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K250552) | ABBOTT MEDICAL | 2025-07-25 |
| MAGiC Sweep™ EP Mapping Catheter (K250590) | Stereotaxis, Inc. | 2025-07-23 |
| HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (K243781) | Edwards Lifesciences | 2025-07-23 |
| CardioTag™ (K243566) | Cardiosense, Inc. | 2025-07-22 |
| TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (K250913) | Jiangsu Tingsn Technology Co., Ltd. | 2025-07-19 |
| HeartFlow Analysis (K250902) | HeartFlow, Inc. | 2025-07-18 |
| Masimo O3 Regional Oximeter (K243324) | Masimo Corporation | 2025-07-17 |
| 0.014” Willow Guidewire (K243756) | Arbor Endovascular, LLC | 2025-07-17 |
| DualView Catheter (K250751) | Terumo Corporation | 2025-07-17 |
| Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) (K251102) | Cemho Medical Technology (Guangdong) Co., Ltd. | 2025-07-16 |
| Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) (K251045) | Unimed Medical Supplies, Inc. | 2025-07-15 |
| Tempus ECG-Low EF (K250119) | Tempus AI, Inc. | 2025-07-15 |
| FLOWRUNNER Aspiration System (K251488) | Expanse Medical, Inc. | 2025-07-14 |
| Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) (K250185) | Jiangxi Aicare Medical Technology Co., Ltd. | 2025-07-14 |
| Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (K241179) | VivaQuant, Inc. | 2025-07-11 |
| Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter (K250772) | Surgical Instrument Service and Savings, Inc. | 2025-07-11 |
| RAP Femoral Venous Cannulae (K250283) | LivaNova USA, Inc. | 2025-07-10 |
| ZBPro Diagnostic (K243252) | Zbeats, Inc. | 2025-07-10 |
| HARBOR Occlusion Device (K250133) | Nuvascular, Inc. | 2025-07-09 |
| Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (K242562) | Ge Medical Systems Information Technologies, Inc. | 2025-07-09 |
| Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) (K240908) | Spectrum Medical , Ltd. | 2025-07-08 |
| Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (K250105) | Aveera Medical, Inc. | 2025-07-03 |
| G0 Blood Pressure Monitoring System (G0) (K250415) | Aktiia SA | 2025-07-02 |
| Primum Hydrophilic Guiding Catheter (K250972) | Pendracare | 2025-06-29 |
| Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (K250610) | Sorin Group Italia S.R.L. | 2025-06-27 |
| CPS Locator 3D Plus Delivery Catheter (K250828) | CenterPoint Systems, LLC | 2025-06-27 |
| VIKING™ Fixed Curve Diagnostic Catheter (K250310) | Boston Scientific Corporation | 2025-06-27 |
| Lap.Ox™ Laparoscopic Tissue Oximeter (K250519) | ViOptix, Inc. | 2025-06-26 |
| Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (K250548) | Joytech Healthcare Co. , Ltd. | 2025-06-26 |
| SAT CenterFlow Molding Balloon Catheter (IN20-00313) (K243184) | Strait Access Technologies Holdings | 2025-06-25 |
| Globe® Pulsed Field System (K250747) | Kardium, Inc. | 2025-06-25 |
| Bridge Plus Occlusion Balloon (590-002) (K251358) | Philips Image Guided Therapy Devices | 2025-06-24 |
| Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) (K250326) | Spectrum Medical S.R.L. | 2025-06-24 |
| FUBUKI XF-R Neurovascular Long Sheath (K251560) | Asahi Intecc Co., Ltd. | 2025-06-20 |
| Us2.ca (K250151) | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2025-06-20 |
| Branchor X Balloon Guide Catheter (K251240) | Asahi Intecc Co., Ltd. | 2025-06-20 |
| Celsi Warmer (K242964) | Hadleigh Health Technologies | 2025-06-20 |
| MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (K251258) | Medtronic, Inc. | 2025-06-20 |
| FloPatch FP120 (K251114) | Flosonics Medical | 2025-06-20 |
| FlexiGo 3D Delivery Catheter (K250492) | CenterPoint Systems, LLC | 2025-06-18 |
| Dorado™ PTA Balloon Dilatation Catheter (K250219) | Bard Peripheral Vascular, Inc. | 2025-06-17 |
| VitalSigns 1-Lead Holter (VSH101) (K243003) | VitalSigns Technology Co., Ltd. | 2025-06-17 |
| Bioptimal Bipolar Pacing Catheter (K242863) | Bioptimal International Pte. , Ltd. | 2025-06-15 |
| Withings ECG App (K240795) | Withings | 2025-06-15 |
| Medtronic Stedi Extra Support Guidewire (K250075) | Medtronic, Inc. | 2025-06-13 |
| Aventus Thrombectomy System (K251189) | Inquis Medical | 2025-06-13 |
| Excipio LV Prime Thrombectomy Device (K251485) | Contego Medical, Inc. | 2025-06-13 |
| Liberant Thrombectomy System (K250787) | Medtronic, Ireland | 2025-06-11 |
| Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (K242737) | Empatica S.r.l. | 2025-06-06 |
| Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (K250545) | Surgical Instrument Service and Savings, Inc. | 2025-06-05 |
| Central Station (K242750) | Nihon Kohden Digital Health Solutions, LLC | 2025-06-05 |
| PhysCade System (K250749) | Physcade, Inc. | 2025-06-04 |
| TeleRehab Aermos Cardiopulmonary Rehabilitation (K250259) | The ScottCare Corporation | 2025-06-04 |
| Raptor Aspiration Catheter; Balt Aspiration Tubing Set (K243948) | Balt USA, LLC | 2025-06-03 |
| Globe Introducer (601-01001) (K250529) | Kardium, Inc. | 2025-06-03 |
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
| LimFlow ARC (K251376) | LimFlow, Inc. | 2025-05-31 |
| VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) (K250150) | Sorin Group Italia S.R.L. | 2025-05-30 |
| Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (K250078) | Mindset Medical, Inc. | 2025-05-30 |
| Prestige Coil System (Prestige Packing Line Extension) (K251383) | Balt USA, LLC | 2025-05-30 |
| Radius VSM and Accessories (K250757) | Masimo Corporation | 2025-05-29 |
| Spur Peripheral Retrievable Stent System (DEN240048) | Reflow Medical, Inc. | 2025-05-29 |
| VersaCross Connect™ Transseptal Dilator (K251325) | Baylis Medical Company, Inc. | 2025-05-29 |
| OptiMap™ System (K251344) | Boston Scientific Corporation | 2025-05-28 |
| Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (K243047) | Imperative Care, Inc. | 2025-05-28 |
| DeepRhythmAI (K250932) | Medicalgorithmics S.A. | 2025-05-27 |
| ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ (K251211) | ABBOTT MEDICAL | 2025-05-23 |
| 93 NeuFlex Catheter (K251044) | Piraeus Medical | 2025-05-23 |
| InVision Precision Cardiac Amyloid (K243866) | InVision Medical Technology Corporation | 2025-05-21 |
| VitalFlow Console (K250199) | Medtronic, Inc. | 2025-05-20 |
| ViewFlex™ X ICE Catheter, Sensor Enabled™ (K251231) | ABBOTT MEDICAL | 2025-05-20 |
| Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (K243601) | Route 92 Medical, Inc. | 2025-05-19 |
| iBSM (K243837) | Iorbit Digital Technologies Private Limited | 2025-05-16 |
| Embosphere Microspheres (K250971) | Biosphere Medical, S.A. | 2025-05-16 |
| Hypertension Prediction Index (HePI) Algorithm (K242518) | Edwards Lifesciences, LLC | 2025-05-15 |
| Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (K251186) | C.R. Bard, Inc. | 2025-05-15 |
| Nitinol Enhanced Device (NED) (K250276) | Embolization, Inc. | 2025-05-15 |
| Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System (K250775) | Imperative Care, Inc. | 2025-05-14 |
| NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (K250592) | Northeast Scientific, Inc. | 2025-05-12 |
| InThrill™ Thrombectomy System (K250421) | Inari Medical, Inc. | 2025-05-12 |
| Avidhrt Sense SpO2 (K241086) | Avidhrt, Inc. | 2025-05-09 |
| VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (K251103) | Philips Image Guided Therapy Corporation | 2025-05-09 |
| PATH BGC (K242392) | Crossroads Neurovascular, Inc. | 2025-05-09 |
| Volta AF-Xplorer (K243812) | Volta Medical | 2025-05-09 |
| Telemetry Monitor 5500 Release 4.0 (867232) (K242962) | Philips Medizin Systeme Böblingen GmbH | 2025-05-05 |
| AeviceMD (K243603) | Aevice Health Pte. , Ltd. | 2025-05-05 |
| SpO2 Extension Cable (K242986) | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2025-05-02 |
| AT-Patch (ATP-C130/ATP-C70) (K242583) | Atsens Co., Ltd. | 2025-05-02 |
| Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo (K250161) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-05-02 |
| Shockwave CS Guide Catheter (K243757) | Shockwave Medical, Inc. | 2025-05-02 |
| APRO 45 Catheter (K251014) | Alembic, LLC | 2025-05-01 |
| CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) (K251007) | Circa Scientific, Inc. | 2025-05-01 |