| Mistral-Air® Warming System (K261437) | The Surgical Company International B.V., doing business as TSC Life | 2026-08-07 |
| Aristotle Mini Guidewire (K260223) | Scientia Vascular, Inc. | 2026-08-06 |
| Telemetry Monitor (iT30, iT50) (K251508) | Edan Instruments, Inc. | 2026-08-06 |
| Vertex™ Thrombectomy System (K261523) | Jupiter Endovascular | 2026-08-04 |
| VueJect® Ultrasound Enhancing Agent Delivery System (K262115) | ACIST Medical Systems, Inc. | 2026-08-03 |
| Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) (K261494) | Shanghai Hulu Devices Co., Ltd. | 2026-07-31 |
| UniPearls® Embolic Microspheres (K252812) | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 |
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Flexitouch® Plus Advanced Pneumatic Compression System (K253555) | Tactile Medical | 2026-07-31 |
| Sync AV II Temporary Pacing Catheter (K252042) | Swift Sync, Inc. | 2026-07-30 |
| CPS Locator 3D Plus Delivery Catheter (K261766) | CenterPoint Systems, LLC | 2026-07-29 |
| SSPC NXT Delivery Catheter (K262240) | CenterPoint Systems, LLC | 2026-07-29 |
| NAMIC Dilator and Sheath (K253526) | Medline Industries, LP | 2026-07-29 |
| CaRi-Heart (DEN250042) | Caristo Diagnostics , Ltd. | 2026-07-28 |
| Powered Aventus Thrombectomy System™ (K261105) | Inquis Medical | 2026-07-27 |
| FlexTract Deflectable-Rotational Dilator Sheath Set (K261310) | Merit Medical Systems, Inc. | 2026-07-27 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (K262201) | Shockwave Medical, Inc. | 2026-07-27 |
| Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (K261759) | Medtronic Ireland | 2026-07-27 |
| CorVista System® with PCWP Add-On (K253576) | Analytics For Life, Inc. | 2026-07-26 |
| Corsano CardioWatch 287-2 System (K261367) | Corsano Health B.V. | 2026-07-26 |
| VERAFEYE Imaging Catheter (VF-VIC-002) (K261849) | Luma Vision Limited | 2026-07-24 |
| FARADRIVE™ Steerable Sheath (M004PF21M402) (K262165) | Boston Scientific Corporation | 2026-07-24 |
| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
| Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (K253277) | Ge Medical Systems Information Technologies, Inc. | 2026-07-24 |
| Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) (K261082) | Microlife Corporation | 2026-07-23 |
| Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) (K261136) | Guangzhou Daxin Health Technology Co., Ltd. | 2026-07-23 |
| CORE 300 Digital Stethoscope (K261694) | Eko Health, Inc. | 2026-07-23 |
| STEDI Scan Device (K253840) | Stroke DX | 2026-07-22 |
| PreludeSYNC™ Radial Compression Device (K262086) | Merit Medical Systems, Inc. | 2026-07-22 |
| Drivewire 35 Guidewire (K254006) | Rapid Medical Ltd. | 2026-07-17 |
| Socrates Aspiration System (Socrates 70 Aspiration Catheter) (K260002) | Scientia Vascular, Inc. | 2026-07-16 |
| Aventus Thrombectomy System (K262030) | Inquis Medical | 2026-07-15 |
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
| Accoat Guide Wire (K253667) | Sp Medical A/S | 2026-07-14 |
| Merit MAK Nitinol/Gold-Tungsten Guide Wire (K261640) | Merit Medical Ireland , Ltd. | 2026-07-13 |
| SLIM Microcatheter (K260199) | Balt USA, LLC | 2026-07-13 |
| Millipede88 Access Catheter (K253901) | Perfuze, Ltd. | 2026-07-09 |
| UbiqVue™ 2AYe Cardiac System (UX2253) (K261569) | Lifesignals, Inc. | 2026-07-09 |
| ScioCardio ECG Analysis Platform (K252978) | Synergen Technology Labs, LLC | 2026-07-09 |
| LifeLens Physiological Monitor (K260157) | LifeLens Technologies, Inc. | 2026-07-09 |
| BlueDop Vascular Expert (K260700) | BlueDop Medical, Ltd. | 2026-07-08 |
| ThermAffyx(TM) Patient Safety System (K260278) | Stihler Electronic GmbH | 2026-07-08 |
| Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) (K261529) | Hartman Medical Group, LLC | 2026-07-06 |
| Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (K261825) | Abbott | 2026-07-02 |
| ILR ECG Analyzer (IM007) (K253463) | Implicity, Inc. | 2026-07-02 |
| SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (K252463) | Edan Instruments, Inc. | 2026-07-02 |
| Trevo Trak 21 Microcatheter (K261889) | Stryker Neurovascular | 2026-07-01 |
| ISAAC Neurovascular Navigation Catheter (K261808) | Microvention Inc. d/b/a Terumo Neuro | 2026-06-30 |
| NorthStar Mapping System (MAP01 or MAP01-01) (K261119) | Imricor Medical Systems, Inc. | 2026-06-30 |
| Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) (K254149) | Sterilmed, Inc. | 2026-06-29 |
| Arterial Pressure Monitoring Set/Tray (K261455) | Spectrum Vascular | 2026-06-26 |
| LightningWire Transseptal Puncture System (TPS) (K261745) | ElectroWire Medical | 2026-06-26 |
| mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) (K253384) | Seers Technology Co., Ltd. | 2026-06-25 |
| SimplGuide (K261242) | Pendracare | 2026-06-25 |
| DVT Garment (K253386) | Vistar Medical Supplies Co., Ltd. | 2026-06-25 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Health Line Tearaway Introducer (K261950) | Health Line International Corporation | 2026-06-22 |
| Medline Reusable Blood Pressure Cuff (K254287) | Medline Industries, LP | 2026-06-22 |
| MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707) | Corcym S.r.l. | 2026-06-18 |
| ZywieZ3 Sensor & Adhesive (K252839) | Zywie, Inc. | 2026-06-18 |
| SmartSpectra Vital Signs Monitor 1.0 (K254169) | Presage Security, Inc. d/b/a Presage Technologies, Inc. | 2026-06-18 |
| Wrist Blood Pressure Monitor (XW-05) (K253126) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-18 |
| Amplatzer TorqVue Exchange System (K261631) | Abbott Medical | 2026-06-17 |
| VicorderCS (VCS-SYS-1100) (K260693) | 80 Beats Medical GmbH | 2026-06-16 |
| Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) (K253059) | Tournicare Pty, Ltd. | 2026-06-15 |
| Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) (K253196) | Midmark Corporation | 2026-06-12 |
| OneStim-DUO Cardiac Stimulator (MP5003-4CO) (K253088) | Micropace Pty, Ltd. | 2026-06-12 |
| HARBOR Occlusion Device (K260635) | Nuvascular, Inc. | 2026-06-12 |
| Verge™ Microcatheter (K261610) | Instylla, Inc. | 2026-06-11 |
| Anura Mobile Core SDK (M1) (K253650) | Nuralogix Corporation | 2026-06-11 |
| Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) (K261329) | Centerline Biomedical | 2026-06-10 |
| Penumbra System (Thunderbolt Aspiration Tubing) (K250690) | Penumbra, Inc. | 2026-06-10 |
| BOBBY Balloon Guide Catheter (K261549) | MicroVention, Inc., d/b/a Terumo Neuro | 2026-06-09 |
| EchoNext (K260332) | Pathwai, Inc. | 2026-06-08 |
| FieldFlex Steerable Sheath (K261492) | CenterPoint Systems, LLC | 2026-06-05 |
| Perfect-O Ostial Positioning Catheter (K260289) | Balosmark, Inc. | 2026-06-05 |
| Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (K260105) | Edwards Lifesciences | 2026-06-05 |
| Radius VSM and Accessories (K254209) | Masimo Corporation | 2026-06-04 |
| Upper arm electronic blood pressure monitor (XB-01) (K253124) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-03 |
| Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) (K252821) | Philips Medizin Systeme Böblingen GmbH | 2026-05-29 |
| M12 Telemetry System (K252840) | Global Instrumentation, LLC | 2026-05-29 |
| ZEUS Platform (FG0501US) (K252859) | iRhythm Technologies, Inc. | 2026-05-29 |
| Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N (K252702) | Bioptimal International Pte. , Ltd. | 2026-05-28 |
| Arc Adjustable Radial Cuff Compression Device (K252772) | Tz Medical, Inc. | 2026-05-22 |
| Spectrum-2 (K254129) | Neko Health AB | 2026-05-22 |
| PCWP Analysis Software (DEN250057) | Cardiosense, Inc. | 2026-05-22 |
| Zenith Distal Access Long Sheath (K253359) | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 |
| InQwire Amplatz Guide Wire (K254137) | Merit Medical Ireland, Ltd. | 2026-05-22 |
| AiSteth® (K252915) | Ai Health Highway India Pvt., Ltd. | 2026-05-22 |
| PanopticAI Vital Signs (1.6.1-22) (K260066) | PanopticAI Technologies Limited | 2026-05-21 |
| WAVE PTA Balloon Catheter (K260304) | WAVE Medical AG | 2026-05-20 |
| Blood Pressure Monitor (W06LT) (K253570) | Shenzhen Jamr Technology Co., Ltd. | 2026-05-20 |
| ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) (K260098) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-20 |
| Zenith Aspiration Catheter; Disposable Aspiration Tubing Set (K252707) | Suzhou Zenith Vascular SciTech Limited | 2026-05-20 |
| The Circadia C300 System (C300) (K261286) | Circadia Health, Inc. | 2026-05-20 |
| TruSelect™ 2.6 Microcatheter (K260771) | Boston Scientific Corporation | 2026-05-15 |
| Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) (K254048) | Shenzhen Urion Technology Co., Ltd. | 2026-05-14 |
| Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr (K252652) | Fortis Biosolutions Company Limited | 2026-05-14 |
| ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable (K252653) | Acist Medical Systems, Inc. | 2026-05-13 |
| VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) (K252638) | Acist Medical Systems, Inc. | 2026-05-13 |