| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) (K253089) | Shenzhen Best Electronics Co., Ltd. | 2026-02-13 |
| Willow 18 Guidewire (K260130) | Arbor Endovascular, LLC | 2026-02-13 |
| Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (K251581) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-02-13 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) (K252685) | Joytech Healthcare Co. , Ltd. | 2026-02-13 |
| PreemptiveAI Clinical SDK (K250233) | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 2026-02-13 |
| Argos Infinity (Rev. 1.0) (K253092) | Retia Medical Systems, Inc. | 2026-02-13 |
| AXS Lift Intracranial Base Catheter (K253032) | Stryker Neurovascular | 2026-02-11 |
| Peel-Away Introducer Sheath (K254236) | VascuTech Medical, LLC | 2026-02-09 |
| Holter ECG and ABP system (HolterABP) (K251591) | Edan Instruments, Inc. | 2026-02-09 |
| SafeBeat Rx App (K251218) | SafeBeat Rx, Inc. | 2026-02-06 |
| IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) (K252726) | Philips Medizin Systeme Boeblingen GmbH | 2026-02-06 |
| Kneevoice Cartilage Evaluation System (750-3600-001) (K252076) | Kneevoice, Inc. | 2026-02-06 |
| CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister (K260028) | Argon Medical Devices, Inc. | 2026-02-05 |
| INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (K251949) | Penumbra, Inc. | 2026-02-05 |
| UltraScore™ Focused Force PTA Balloon (K260012) | Bard Peripheral Vascular, Inc. | 2026-02-04 |
| The Circadia C300 System (C300) (K252676) | Circadia Health, Inc. | 2026-02-03 |
| Vital Signs (K251200) | Oxehealth Limited | 2026-02-02 |
| CHIKAI Nexus petit (K252011) | Asahi Intecc Co., Ltd. | 2026-02-02 |
| Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (K253847) | Merit Medical Ireland, Ltd. | 2026-01-31 |
| Dual Stage Venous Cannulae (K253671) | Sorin Group Italia S.R.L. | 2026-01-30 |
| MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (K253224) | ImpediMed Limited | 2026-01-28 |
| NorthStar™ Mapping System (K252164) | Imricor Medical Systems | 2026-01-28 |
| Sleepiz One+ (Model 2.5) (K253388) | Sleepiz AG | 2026-01-28 |
| MAC 7 Resting ECG Analysis System (K251670) | Ge Medical Systems Information Technologies, Inc. | 2026-01-26 |
| BodyGuardian Remote Monitoring System (BGRMS v3.0) (K243349) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026-01-23 |
| Perin Health System (PHD80060-2) (K252984) | Perin Health Devices, LLC | 2026-01-22 |
| Genie MAX Large Bore Introducer Sheath (K253652) | Cultiv8 1, LLC | 2026-01-22 |
| InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) (K251385) | Merit Medical Ireland, Ltd. | 2026-01-21 |
| RoVo Mechanical Thrombectomy System (K253730) | Verge Medical, Inc. | 2026-01-21 |
| VariFuse Adjustable Infusion Catheter (K251318) | Argon Medical Devices, Inc. | 2026-01-20 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Baylis Connector Cable (K254114) | Baylis Medical Technologies, Inc. | 2026-01-18 |
| CARTO™ 3 EP Navigation System V9.0 with PIU Plus (K254085) | Biosense Webster, Inc. | 2026-01-18 |
| Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (K251970) | Medtronic, Ireland | 2026-01-17 |
| Toro 88 Superbore Catheter (K252297) | Toro Neurovascular, Inc. | 2026-01-16 |
| WAVE Clinical Platform (2.0.000) (K250135) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
| OptoMonitor 3 (K251367) | Opsens, Inc. | 2026-01-16 |
| Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter (K251744) | Medtronic | 2026-01-16 |
| Aventus Thrombectomy System (K253925) | Inquis Medical | 2026-01-15 |
| Esperance pHLO Aspiration System (K251357) | Phenox, Ltd. | 2026-01-15 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (K251307) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-01-12 |
| Disposable Neonatal NIBP Cuff (U1681S-C51N) (K253964) | Unimed Medical Supplies, Inc. | 2026-01-09 |
| Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (K253142) | Ningbo Ranor Medical Technology Co., Ltd. | 2026-01-09 |
| Solo Pace Fusion System (SOLOFUSE1) (K252674) | Solo Pace, Inc. | 2026-01-09 |
| Corvair Monza (K252589) | AliveCor, Inc. | 2026-01-09 |
| Vision-MR™ Diagnostic Catheter (K252794) | Imricor Medical Systems, Inc. | 2026-01-08 |
| Sangria™ Thrombectomy System (K251207) | Avantec Vascular Corporation | 2026-01-07 |
| Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (K253109) | Shenzhen Best Electronics Co., Ltd. | 2026-01-07 |
| Reprocessed Agilis NxT Steerable Introducer (K250305) | Innovative Health | 2026-01-07 |
| V-DAC Catheter (K251097) | Vesalio, Inc. | 2026-01-06 |
| SurfRider 13 Microcatheter (K251668) | Kaneka Americas Holding, Inc. | 2026-01-05 |
| Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) (K243627) | Arc Trauma, LLC | 2025-12-31 |
| Pression Wave PRO External Counter-Pulsation System (K250756) | Pression, Inc. | 2025-12-22 |
| Inspire HCR and HCR DUAL cardiotomy reservoirs (K251783) | Sorin Group Italia S.R.L. | 2025-12-22 |
| AccurECG Analysis System (v2.0) (K252361) | Accurkardia, Inc. | 2025-12-22 |
| Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (K251143) | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2025-12-19 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |
| Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (K250314) | Surgical Instrument Service and Savings, Inc. | 2025-12-19 |
| Spo2 Sensor CSS032D (K251751) | Shenzhen Ykd Technology Co., Ltd. | 2025-12-19 |
| STAR Apollo™ Mapping System (K253733) | Rhythm AI, Ltd. | 2025-12-19 |
| eMurmur Heart AI (K252284) | Csd Labs | 2025-12-19 |
| ProtekDilate Vascular Access Kit (K253616) | Sorin Group Italia S.R.L. | 2025-12-19 |
| Amethyst HP PTA OTW 0.035 Catheter (K251915) | Natec Medical , Ltd. | 2025-12-18 |
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (K252533) | Edwards Lifesciences | 2025-12-18 |
| Helo Thrombectomy System (K252956) | Endovascular Engineering, Inc. | 2025-12-18 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |
| Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (K252417) | ABBOTT MEDICAL | 2025-12-17 |
| Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) (K250854) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-17 |
| Intri26 Introducer Sheath (K252508) | Inari Medical, Inc. | 2025-12-17 |
| Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (K251745) | Baxter Healthcare Corporation | 2025-12-16 |
| prolaio eVO2peak Module (Version 1.0) (K252204) | Prolaio, Inc. | 2025-12-16 |
| Tembo Embolic System (K253677) | Instylla, Inc. | 2025-12-15 |
| V•Stick™ Vascular Access Set (K253741) | Argon Medical Devices, Inc. | 2025-12-15 |
| Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) (K250821) | Eurosets S.R.L | 2025-12-12 |
| Bio Arterial Deluxe (IC-BAP-DX) (K250974) | Bio Compression Systems, Inc. | 2025-12-12 |
| DeepRhythmAI (K253141) | Medicalgorithmics S.A. | 2025-12-11 |
| HeartBeam AIMIGo with 12-L ECG Synthesis Software System (K250258) | Heartbeam, Inc. | 2025-12-08 |
| Sequential Compression System (SCD600) (K250190) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-08 |
| MEMO Patch M (MPT-E08R-UNC01) (K243438) | Huinno Co., Ltd. | 2025-12-05 |
| MitraPatch Mitral Valve Repair System (K252126) | Chawla Heart Technologies, LLC | 2025-12-04 |
| Vektor Computational ECG Mapping System (vMap®) (K252429) | Vektor Medical, Inc. | 2025-12-04 |
| Bendit17 Microcatheter (K252213) | Bend IT Technologies, Ltd. | 2025-12-03 |
| VitaloJAK Clinic (Model 7100) (K253293) | Vitalograph , Ltd. | 2025-12-03 |
| Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) (K251691) | Unimed Medical Supplies, Inc. | 2025-12-01 |
| Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) (K251696) | Unimed Medical Supplies, Inc. | 2025-12-01 |
| IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) (K252827) | Drägerwerk AG & Co. KGaA | 2025-12-01 |
| Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter (K252405) | Surgical Instrument Service and Savings, Inc. | 2025-11-26 |
| 0.014” Willow Guidewire (K253168) | Arbor Endovascular, LLC | 2025-11-26 |
| FEops HEARTguide Simulation Application (K250635) | Feops NV | 2025-11-25 |
| Akura Thrombectomy System (K251070) | Akura Medical | 2025-11-25 |
| Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (K242503) | Eurosets S.R.L | 2025-11-24 |
| BCM2-Body Composition Monitor (K250634) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 |
| NeVa PV Thrombectomy Device (K253407) | Vesalio, Inc. | 2025-11-24 |
| AlphaVac Multipurpose Mechanical Aspiration System F1885 (K252509) | AngioDynamics, Inc. | 2025-11-24 |
| CardioVision (K251293) | Icardio.Ai | 2025-11-21 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) (K251904) | Remington Medical, Inc. | 2025-11-20 |
| Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (K253070) | Medline Industries, LP | 2025-11-20 |