| K253075 — Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253639 — View | GE Healthcare Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253370 — LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253266 — Titanium Interbody System | Spine Innovation, LLC Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252585 — ZENEX Implant System_R-System | Izenimplant Co., Ltd. Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252711 — Advantage-C Ti3D Cervical Interbody Fusion Device | Intelivation Technologies Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252669 — Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co., Ltd. Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252759 — revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252794 — Vision-MR Diagnostic Catheter | Imricor Medical Systems, Inc. Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253784 — 3DICOM MD Cloud | Singular Health Pty, Ltd. Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253512 — MiniMed Go App | Medtronic Minimed Thu Jan 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250305 — Reprocessed Agilis NxT Steerable Introducer | Innovative Health Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252727 — Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253939 — DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253924 — PuraStat | 3-D Matrix Europe SAS Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253941 — CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | Materialise NV Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251207 — Sangria Thrombectomy System | Avantec Vascular Corporation Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253366 — LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253158 — VyBrate VBR System | Vy Spine, LLC Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252507 — SmileInspector | Amv Consulting, LLC Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253009 — DS Core Detect | Dentsply Sirona, Inc. Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253923 — PuraStat | 3-D Matrix Europe SAS Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252970 — BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251454 — Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252890 — ZenSeal Pro | Kerr Corporation Wed Jan 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252886 — Pen Needle | Hh Global Technology, Inc. Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253618 — QuadLock Fixation System | Abanza Tecnomed S.L Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251165 — Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252749 — Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250341 — Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251097 — V-DAC Catheter | Vesalio, Inc. Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253178 — TRILEAP Plating System | Crossroads Extremity Systems Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253793 — Materialise TKA Guide System | Materialise NV Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252894 — aprevo® cervical interbody system | Carlsmed, Inc. Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252988 — ChartCheck (RADCH V1.6) | Radformation, Inc. Mon Jan 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251630 — Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. Mon Jan 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252650 — Disposable Medical Face Mask | Makrite Industries, Inc. Mon Jan 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252018 — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Mon Jan 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251757 — Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. Mon Jan 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253008 — maiLink | Maihub Corp. Mon Jan 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251668 — SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. Mon Jan 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253867 — FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG Fri Jan 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252817 — Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. Fri Jan 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251178 — Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation Fri Jan 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |