| ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K252281) | Ulrich GmbH & Co. KG | 2025-11-18 |
| Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) (K251695) | Unimed Medical Supplies, Inc. | 2025-11-18 |
| Hexoskin Medical System (7100-00016) (K243981) | Carre Technologies, Inc. | 2025-11-18 |
| Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) (K251693) | Unimed Medical Supplies, Inc. | 2025-11-18 |
| TELLTALE Electrosurgical Guidewire System (K252592) | Telltale, LLC | 2025-11-13 |
| NeVasc Aspiration System (K251006) | Vesalio, Inc. | 2025-11-10 |
| Withings BeamO (SCT02) (K252474) | Withings | 2025-11-10 |
| IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) (K251702) | Philips Medizin Systeme Böblingen GmbH | 2025-11-10 |
| Lunderquist Extra Stiff Wire Guide (K251596) | William Cook Europe Aps | 2025-11-09 |
| ulrichINJECT CT Motion (XD 8000) (K251295) | Ulrich GmbH & Co. KG | 2025-11-07 |
| Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (K251792) | Stereotaxis, Inc. | 2025-11-06 |
| Zoom System (Zoom 4S Catheter) (K252046) | Imperative Care, Inc. | 2025-10-30 |
| OBSIDIO™ Conformable Embolic (M0013972101010) (K253376) | Boston Scientific Corporation | 2025-10-30 |
| Arctx Cool Catheter Set (K250632) | Arctx Medical | 2025-10-30 |
| Telescope Guide Extension Catheter (K252390) | Medtronic, Ireland | 2025-10-29 |
| Protrieve Sheath (K253323) | Inari Medical | 2025-10-29 |
| Seguin Annuloplasty Ring (K253232) | ABBOTT MEDICAL | 2025-10-29 |
| Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (K253399) | Volcano Corporation (Dba Philips Image Guided Therapy Device | 2025-10-28 |
| VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr (K251466) | Wellell, Inc. | 2025-10-28 |
| Blood Pressure Monitor (B73, BE23T) (K251331) | Shenzhen Jamr Technology Co., Ltd. | 2025-10-27 |
| Vesalio Peripheral System (K251312) | Vesalio, Inc. | 2025-10-24 |
| AngioVac Cannula (K253106) | AngioDynamics, Inc. | 2025-10-24 |
| LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (K252645) | Philips Medical Systems Nederland B.V. | 2025-10-24 |
| Arctic Sun Temperature Management System (Model 5000) (K251974) | Medivance, Inc. | 2025-10-24 |
| CoroFlow Cardiovascular System (K252238) | Coroventis Research AB | 2025-10-24 |
| VersaD Delivery Catheter (K251372) | Unity Medical, Inc. | 2025-10-24 |
| PerQseal Introducers (K252309) | Vivasure Medical Limited | 2025-10-23 |
| Carrier XL Delivery Catheter (K252569) | Balt USA, LLC | 2025-10-22 |
| XC11 ICE System, USA (K250955) | Yorlabs, Inc. | 2025-10-22 |
| Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) (K251185) | Intervene | 2025-10-22 |
| HemoSphere Stream Module (K253034) | Edwards Lifesciences | 2025-10-21 |
| Introducer Sheath Set (K251838) | Cardiocycle Medical(Suzhou) Co., Ltd. | 2025-10-21 |
| Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (K252277) | Vascular Flow Technologies Limited | 2025-10-20 |
| IntelliVue Patient monitors MX400, MX450, MX500, MX550 (K251146) | Philips Medizin Systeme Boeblingen GmbH | 2025-10-17 |
| SureAx-Guide™ (K250203) | Sureax Medical, LLC | 2025-10-17 |
| INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing (K252612) | Penumbra, Inc. | 2025-10-16 |
| Re:Balans (K243727) | Mode Sensors AS | 2025-10-16 |
| Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) (K250979) | Zoll Circulation, Inc. | 2025-10-15 |
| LIFEPAK 15 AC Power Adapter (41577-000333) (K253099) | Physio-Control, Inc. | 2025-10-14 |
| Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (K251795) | Honsun (Nantong) Co., Ltd. | 2025-10-09 |
| 14Fr Low Profile Introducer Kit (K252766) | Abiomed, Inc. | 2025-10-08 |
| Tigertriever 17 Ultra Revascularization Device (K251603) | Rapid Medical Ltd. | 2025-10-06 |
| Amplatzer Guidewire (K250031) | ABBOTT MEDICAL | 2025-10-03 |
| EasyTeleMed (2.0.2) (K252440) | Ingeniars S.R.L. | 2025-10-02 |
| Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) (K252769) | Shenzhen Finicare Co., Ltd. | 2025-10-02 |
| IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter (K251669) | Shanghai Draeger Medical Instrument Co., Ltd. | 2025-09-30 |
| Biopsy Forceps (K252722) | Fehling Instruments GmbH | 2025-09-30 |
| TigerConnect Alarm Management (K243270) | Tigerconnect | 2025-09-30 |
| Primero Safe Access System (K252441) | South53, LLC | 2025-09-29 |
| VitalStream ART Connect; VitalStream-Hemo (K251275) | Caretaker Medical | 2025-09-26 |
| EnSite™ X EP System (K252013) | ABBOTT MEDICAL | 2025-09-25 |
| Pulse Oximeter (K250837) | Shanghai Berry Electronic Tech Co., Ltd. | 2025-09-25 |
| EMBOTRAP III Revascularization Device (K251789) | Neuravi Limited | 2025-09-25 |
| Pounce(TM) Sheath (K252227) | Surmodics,Inc. | 2025-09-24 |
| MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (K252689) | Imaxeon Pty, Ltd. | 2025-09-24 |
| Polyvinyl Alcohol Embolic Microspheres (K250209) | Canyon Medical, Inc. | 2025-09-23 |
| Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) | Edwards Lifesciences, LLC | 2025-09-23 |
| Santreva™-ATK Endovascular Revasculariztion Catheter (K252315) | AngioSafe, Inc. | 2025-09-22 |
| Bunkerhill ECG-EF (K250649) | BunkerHill Health | 2025-09-19 |
| PlasmaFlow X Compression Sleeve Device (XPF0001) (K251446) | Manamed, LLC | 2025-09-17 |
| Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (K251221) | Abbott | 2025-09-17 |
| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
| Vertex(TM) Catheter (K252027) | Jupiter Endovascular | 2025-09-12 |
| Volta AF-Xplorer II (K251518) | Volta Medical | 2025-09-12 |
| LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) (K252593) | Boston Scientific Corporation | 2025-09-12 |
| Stethophone Pro (K252595) | Sparrow Acoustics, Inc. | 2025-09-12 |
| Hypertension Notification Feature (HTNF) (K250507) | Apple, Inc. | 2025-09-11 |
| PowerWire® 14 Radiofrequency Guidewire Kit (K251158) | Baylis Medical Technologies, Inc. | 2025-09-11 |
| Surfacer Inside-Out Access Catheter System (K252527) | Merit Medical System, Inc. | 2025-09-10 |
| Edema Guard Monitor (EGM) CardioSet-001 (K250922) | Cardioset Medical , Ltd. | 2025-09-09 |
| DUO Microcatheter (K250960) | Rev Neuro, LLC | 2025-09-08 |
| High Pressure Tubing (K244038) | Shandong Int Medical Instruments Co., Ltd. | 2025-09-05 |
| pREBOA-PRO Catheter (K243795) | Prytime Medical Devices, Inc. | 2025-09-05 |
| LIBERTY Endovascular Robotic System (LIBERTYOS) (K243789) | Microbot Medical , Ltd. | 2025-09-04 |
| EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) (K251463) | ABBOTT MEDICAL | 2025-09-04 |
| Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) (K250231) | Dongguan E-Test Technology Co., Ltd. | 2025-09-03 |
| AViTA Arm Type Blood Pressure Monitor Cuff (K250765) | Avita Corporation | 2025-09-03 |
| IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) (K250453) | Philips Medizin Systeme Böblingen GmbH | 2025-09-02 |
| Edwards eSheath Optima introducer set (K252364) | Edwards Lifesciences | 2025-08-29 |
| Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (K252392) | Perfuze, Ltd. | 2025-08-29 |
| Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) (K251181) | Merit Medical Ireland, Ltd. | 2025-08-29 |
| Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (K252057) | Imperative Care, Inc. | 2025-08-28 |
| Vital Signs (K243687) | Oxehealth Limited | 2025-08-27 |
| QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (K241766) | Fysicon BV | 2025-08-27 |
| HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (K252419) | Atraverse Medical, Inc. | 2025-08-27 |
| X-Wire Guidewire (K244061) | Imperative Care, Inc. | 2025-08-26 |
| CPS Locator 3D Delivery Catheter (K250147) | Centerpoint Systems | 2025-08-22 |
| CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (K251828) | Cerenovus, Inc. | 2025-08-22 |
| CoraForce Microcatheter, CoraFlex Microcatheter (K251277) | Reflow Medical, Inc. | 2025-08-22 |
| CARTO™ 3 EP Navigation System V8.1 (K252302) | Biosense Webster, Inc. | 2025-08-22 |
| PnueAira (PNCU-01) (K251086) | Biotab, LLC | 2025-08-18 |
| Zio® monitor (DFG0001) (K243650) | iRhythm Technologies, Inc. | 2025-08-15 |
| Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) (K250931) | Unimed Medical Supplies, Inc. | 2025-08-13 |
| Eko Foundation Analysis Software with Transformers (EFAST) (K251494) | Eko Health, Inc. | 2025-08-12 |
| Coretech Compression System (Coretech RHB3003) (K250817) | Vive Health, LLC | 2025-08-08 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) (K251120) | Microlife Corporation | 2025-08-06 |
| Cardiologs Holter Platform (K250569) | Philips France Commercial | 2025-08-06 |
| Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) (K251762) | Spectrum Medical S.R.L. | 2025-08-04 |
| iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr (K251113) | Andon Health Co, Ltd. | 2025-08-04 |
| BeneVision Central Monitoring System (K242728) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 |