| K252260 — RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. Nov 26, 2025 |
| K252388 — Vanquish Water Vapor Ablation Device | Francis Medical, Inc. Nov 26, 2025 |
| K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | ACON Laboratories, Inc. Nov 26, 2025 |
| K251674 — Fenom Flo FeNO Monitoring System | Mgc Diagnostics Corporation Nov 26, 2025 |
| K251058 — Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health Nov 26, 2025 |
| K252405 — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service And Savings, Inc. Nov 26, 2025 |
| K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. Nov 26, 2025 |
| K252248 — CEREC Tessera Abutment System | Dentsply Sirona Nov 26, 2025 |
| K253269 — OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. Nov 26, 2025 |
| K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation Nov 25, 2025 |
| K252161 — Hushd Avera | Good Sleep CO Pte , Ltd. Nov 25, 2025 |
| K253310 — 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote, S.P.A. Nov 25, 2025 |
| K251932 — Spectra Platinum | Uzinmedicare Co., Ltd. Nov 25, 2025 |
| K252289 — Eva Scalp Cooling System | Stemtech Medical Devices Private Limited Nov 25, 2025 |
| K252762 — HALO AP Dx | Indica Labs, LLC Nov 25, 2025 |
| K252610 — ZSFab Lumbar Interbody System | Zsfab, Inc. Nov 25, 2025 |
| K251070 — Akura Thrombectomy System | Akura Medical Nov 25, 2025 |
| K253304 — IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) | Dongguan Lide Electric Appliance Co., Ltd. Nov 25, 2025 |
| K252555 — Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC Nov 25, 2025 |
| K253219 — LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. Nov 25, 2025 |
| K251798 — RCT700 | Ray Co., Ltd. Nov 25, 2025 |
| K250635 — FEops HEARTguide Simulation Application | Feops NV Nov 25, 2025 |
| 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 |