| K251550 — NX01 (NX01) | Naox Technologies Sas Nov 25, 2025 |
| K250694 — Scaida BrainCT-ICH (v1.0) | Mlhealth 360 Nov 25, 2025 |
| K253365 — LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. Nov 25, 2025 |
| K253344 — BELLUS-Q | Speclipse, Inc. Nov 25, 2025 |
| K251401 — PennPET Explorer Positron Emission Tomograph | Trustees Of The University Of Pennsylvania Nov 25, 2025 |
| K252004 — enCore Night Guard | Encore Guards Nov 25, 2025 |
| K252253 — Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG Nov 25, 2025 |
| K252328 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound And Primary Care Diagnostics Nov 24, 2025 |
| K252771 — Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Nov 24, 2025 |
| K251631 — The BAG manual resuscitator and accessories | Laerdal Medical AS Nov 24, 2025 |
| K250769 — Dakota LP System | Precision Spine, Inc. Nov 24, 2025 |
| K250634 — BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC Nov 24, 2025 |
| K252787 — Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Nov 24, 2025 |
| K253407 — NeVa PV Thrombectomy Device | Vesalio, Inc. Nov 24, 2025 |
| K252704 — F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | F Care Systems USA, LLC Nov 24, 2025 |
| K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L Nov 24, 2025 |
| K252366 — a2z-Unified-Triage | A2Z Radiology Ai, Inc. Nov 24, 2025 |
| K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. Nov 24, 2025 |
| K252509 — AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. Nov 24, 2025 |
| K250927 — KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG Nov 22, 2025 |
| K252687 — Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd Nov 21, 2025 |
| K250700 — Pen Injector Needle 32.5 | Terumo Corporation Nov 21, 2025 |
| K251880 — Archy Dental Imaging | Archy Dental, Inc. Nov 21, 2025 |
| K250560 — BEE HA | NGMedical GmbH Nov 21, 2025 |
| K252666 — Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC Nov 21, 2025 |
| K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | Everyway Medical Instruments Co.,Ltd Nov 21, 2025 |
| K253681 — TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy, Inc. Nov 21, 2025 |
| K252696 — LEGACY | Phasor Health, LLC Nov 21, 2025 |
| K251607 — Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. Nov 21, 2025 |
| K251293 — CardioVision | Icardio.Ai Nov 21, 2025 |
| K251205 — Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona Nov 21, 2025 |
| K251849 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. Nov 21, 2025 |
| K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. Nov 21, 2025 |
| K251506 — Nelli (Version 7.11) | Neuro Event Labs OY Nov 21, 2025 |
| K252590 — Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. Nov 21, 2025 |
| K250714 — FluoroDose Varnish | Centrix, Inc. Nov 21, 2025 |
| K252686 — EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC Nov 21, 2025 |
| K252070 — Ceribell Infant Seizure Detection Software | Ceribell, Inc. Nov 21, 2025 |
| K243753 — cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. Nov 20, 2025 |
| K251365 — OptumSI Implant System | Si Solutions, LLC Nov 20, 2025 |
| K251904 — 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) | Remington Medical, Inc. Nov 20, 2025 |
| K253105 — HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics Nov 20, 2025 |
| K253324 — UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. Nov 20, 2025 |
| K251822 — MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. Nov 20, 2025 |
| K253495 — syngo.MR Applications (VB80) | Siemens Healthineers AG Nov 20, 2025 |
| K242606 — Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. Nov 20, 2025 |
| K252625 — The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC Nov 20, 2025 |
| K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | Medline Industries, LP Nov 20, 2025 |
| K252846 — TaperSet Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics Nov 20, 2025 |
| K250643 — Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. Nov 20, 2025 |