| ANNE View, Central Hub (K242842) | Sibel Health, Inc. | 2025-01-08 |
| COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (K242588) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-01-07 |
| Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) (K243049) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2025-01-02 |
| Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (K241388) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025-01-02 |
| MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) (K243224) | ABBOTT MEDICAL | 2024-12-31 |
| Next Generation Access Platform (K242376) | Balt USA, LLC | 2024-12-30 |
| Angiography Injector (K242143) | Shandong Int Medical Instruments Co., Ltd. | 2024-12-23 |
| PanopticAI Vital Signs (K240890) | PanopticAI technologies Limited | 2024-12-23 |
| KIDS Arterial Filters (K242953) | Sorin Group Italia S.R.L. | 2024-12-20 |
| Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (K241411) | Welch Allyn, Inc. | 2024-12-20 |
| SENDERO MAX Delivery Catheter (K242644) | Okami Medical, Inc. | 2024-12-20 |
| Broadway 8 Catheter (K241768) | Stryker Neurovascular | 2024-12-19 |
| Echo Intracranial Base Catheter (K241637) | Stryker Neurovascular | 2024-12-19 |
| Shadow Catheter (K240885) | Simpson Interventions, Inc. | 2024-12-19 |
| Falcon/Xpress (Falcon/Xpress) (K242662) | Viasonix , Ltd. | 2024-12-18 |
| Amethyst HP PTA OTW 0.035 Catheter (K241040) | Natec Medical , Ltd. | 2024-12-18 |
| Cardiac Workstation (5000); Cardiac Workstation (7000) (K241556) | Philips Medizin Systeme Böblingen GmbH | 2024-12-17 |
| TEMBO Embolic System (K240873) | Instylla, Inc. | 2024-12-16 |
| Agilis NxT Steerable Introducer Dual-Reach (K243493) | ABBOTT MEDICAL | 2024-12-13 |
| HeartBeam AIMIGo(TM) System (K231424) | Heartbeam, Inc. | 2024-12-13 |
| Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) (K243540) | Ge Medical Systems Information Technologies, Inc. | 2024-12-12 |
| Access25™ Delivery Microcatheter (K242033) | Penumbra, Inc. | 2024-12-11 |
| Prelude Small O.D. Introducer Guide Wire (K241521) | Merit Medical Systems, Inc. | 2024-12-10 |
| Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (K243216) | Analog Devices | 2024-12-10 |
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (K242451) | Edwards Lifesciences | 2024-12-09 |
| PTFE Guidewire (K242824) | Lake Region Medical | 2024-12-06 |
| 87 NeuGlide Catheter (K240971) | Piraeus Medical | 2024-12-06 |
| Magnetic Localization Patch Kit (AFR-00021) (K243435) | Medtronic, Inc. | 2024-12-05 |
| DeepRhythmAI (K241197) | Medicalgorithmics S.A. | 2024-12-04 |
| SSPC NXT Delivery Catheter (K243180) | CenterPoint Systems, LLC | 2024-12-04 |
| Socrates 38 Catheter (K242301) | Scientia Vascular, Inc. | 2024-12-04 |
| Evie Med Ring (K241090) | Movano Inc. Dba Movano Health | 2024-11-29 |
| Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (K242225) | Surgical Instrument Service and Savings, Inc. | 2024-11-29 |
| R2P Radifocus Glidewire Advantage (K240818) | Terumo Corporation | 2024-11-26 |
| Arm Blood Pressure Monitor (model: BPM-A7VL) (K243118) | Shenzhen Imdk Medical Technology Co., Ltd. | 2024-11-26 |
| Cross Wise™ Multi-Use RF Adapter Cable (K243193) | Circa Scientific, Inc. | 2024-11-26 |
| AccurSound Electronic Stethoscope (AS101) (K242971) | Heroic Faith International , Ltd. | 2024-11-25 |
| Versus™ Catheter (VS110-8B) (K241851) | Liquet Medical, Inc. | 2024-11-25 |
| Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH (K232520) | Shenzhen Smallsignal Technology Co., Ltd. | 2024-11-21 |
| Element Vascular Access System (K242520) | Penumbra, Inc. | 2024-11-20 |
| Neurovascular Access System Family (K240746) | Q'Apel Medical, Inc. | 2024-11-20 |
| Informed Vital Core Application (IVC App) (K241633) | Mindset Medical, Inc. | 2024-11-18 |
| MICRO Arterial Filters (K242092) | Sorin Group Italia S.R.L. | 2024-11-18 |
| Synxess Neurovascular Guidewire (K240871) | Enlight Medical Technologies (Shenzhen) Co., Ltd. | 2024-11-18 |
| 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K242419) | Creagh Medical Ltd. Dba Surmodics, Inc. | 2024-11-15 |
| Gelsoft™ Plus Vascular Prostheses (K241070) | Vascutek, Ltd. | 2024-11-15 |
| EchoGo Amyloidosis (1.0) (K240860) | Ultromics Limited | 2024-11-15 |
| Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) (K241224) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2024-11-15 |
| Hinscope (K241397) | Hinlab Sas | 2024-11-14 |
| Nonin OTC Pulse Oximeter Model 3250 (K211498) | Nonin Medical, Inc. | 2024-11-13 |
| pNOVUS 21 Microcatheter (K242420) | Phenox, Ltd. | 2024-11-12 |
| UbiqVue™ 2A Multi-parameter System (UX2550) (K242018) | Lifesignals, Inc. | 2024-11-12 |
| esolution® Esophageal Retractor (K243233) | S4 Medical Corp. | 2024-11-09 |
| Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) (K242756) | Pulnovo Medical (Wuxi) Co., Ltd. | 2024-11-08 |
| Frontier X Plus (K240794) | Fourth Frontier Technologies Pvt, Ltd. | 2024-11-08 |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K240997) | ABBOTT MEDICAL | 2024-11-06 |
| MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (K241849) | Imaxeon Pty, Ltd. | 2024-11-05 |
| FreedomFlow™ Orbital Circumferential Atherectomy System (K242947) | Cardio Flow Inc., | 2024-11-05 |
| SonoStik Guide Wire Introducer (K243061) | Sonostik, LLC | 2024-11-04 |
| EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter (K240366) | Boston Scientific Corporation | 2024-11-01 |
| VersaCross™ RF Wire (K242076) | Baylis Medical Company | 2024-11-01 |
| Affera Integrated Mapping System; Impedance Localization Patch Kit (K241828) | Medtronic, Inc. | 2024-11-01 |
| SmartCardia 7L Platform (MCT) (K240653) | Smartcardia SA | 2024-10-31 |
| Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (K242623) | Shenzhen Medke Technology Co., Ltd. | 2024-10-31 |
| Zio AT® device (A100A1001) (K240177) | iRhythm Technologies, Inc. | 2024-10-30 |
| Riptide Aspiration System (K243080) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-10-29 |
| Pantera Pro; Pantera LEO (K242969) | Biotronik, Inc. | 2024-10-25 |
| Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) (K240092) | Shenzhen Yimi Life Technology Co., Ltd. | 2024-10-25 |
| Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (K241007) | Shenzhen Urion Technology Co., Ltd. | 2024-10-24 |
| Arm Type Blood Pressure Monitor (BPM82) (K242193) | Avita Corporation | 2024-10-22 |
| Tri-Wedge PTA Scoring Balloon Dilatation Catheter (K241478) | Brosmed Medical Co., Ltd. | 2024-10-22 |
| 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) (K241758) | Stryker Sustainability Solutions | 2024-10-22 |
| Zio AT® device (A100A1001) (K240029) | iRhythm Technologies, Inc. | 2024-10-21 |
| Zipline Access Catheter (K240711) | Perfuze, Ltd. | 2024-10-17 |
| Cerebral Autoregulation Index (CAI) Algorithm (K240596) | Edwards Lifesciences | 2024-10-16 |
| CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K241221) | Cerenovus, Inc. | 2024-10-16 |
| CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (K241244) | Cerenovus, Inc. | 2024-10-16 |
| Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) (K241613) | Shenzhen Hbcare Technology Co.,Ltd | 2024-10-16 |
| ONCOZENE Microspheres (K242794) | Varian Medical Systems, Inc. | 2024-10-16 |
| Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (K241894) | Inari Medical, Inc. | 2024-10-15 |
| ARTAIRA Arterial Compression Device (AACD01) (K240499) | Airos Medical, Inc. | 2024-10-11 |
| Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (K242133) | Centerline Biomedical, Inc. | 2024-10-11 |
| Belun Ring BLR-200 (BLR-200) (K234110) | Belun Technology Company Limited | 2024-10-11 |
| Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (K240826) | Sterilmed, Inc. | 2024-10-11 |
| Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) (DEN230076) | Omron Healthcare, Inc. | 2024-10-08 |
| AuST Steerable Sheath (K242106) | CenterPoint Systems, LLC | 2024-10-04 |
| Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) (K242721) | Shenzhen Finicare Co., Ltd. | 2024-10-04 |
| UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF (K241746) | United Medical Resources, LLC | 2024-10-04 |
| OBSIDIO™ Conformable Embolic (K242507) | Boston Scientific | 2024-10-03 |
| Pulse Oximeter (WS20A) (K240808) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2024-10-03 |
| 8F Modified Sheath System (K240529) | Route 92 Medical, Inc. | 2024-10-02 |
| Esperance 3+ Aspiration Catheter System (K240917) | Wallaby Medical | 2024-10-01 |
| CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) (K242276) | Vantis Vascular, Inc. | 2024-09-30 |
| AMC Health CareConsole (K233446) | Amc Health | 2024-09-27 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (K242213) | Shockwave Medical, Inc. | 2024-09-27 |
| ShortCut (DEN240017) | Pi-Cardia, Ltd. | 2024-09-27 |
| ClotTriever XL Catheter (41-102) (K242557) | Inari Medical, Inc. | 2024-09-27 |
| CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) (K241414) | Circa Scientific, Inc. | 2024-09-26 |
| BioButton System (K241101) | Biointellisense, Inc. | 2024-09-26 |
| Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K242075) | Penumbra, Inc. | 2024-09-25 |