| DEN240077 — MuReva OM | Mureva Phototherapy, Inc. Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251674 — Fenom Flo FeNO Monitoring System | Mgc Diagnostics Corporation Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251058 — Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252405 — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252248 — CEREC Tessera Abutment System | Dentsply Sirona Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252388 — Vanquish Water Vapor Ablation Device | Francis Medical, Inc. Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | ACON Laboratories, Inc. Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253269 — OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252610 — ZSFab Lumbar Interbody System | Zsfab, Inc. Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251550 — NX01 (NX01) | Naox Technologies Sas Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252161 — Hushd Avera | Good Sleep CO Pte , Ltd. Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250694 — Scaida BrainCT-ICH (v1.0) | Mlhealth 360 Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252289 — Eva Scalp Cooling System | Stemtech Medical Devices Private Limited Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252555 — Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251070 — Akura Thrombectomy System | Akura Medical Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253219 — LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253310 — 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote, S.p.A. Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250635 — FEops HEARTguide Simulation Application | Feops NV Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251932 — Spectra Platinum | Uzinmedicare Co., Ltd. Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251798 — RCT700 | Ray Co., Ltd. Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253365 — LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253344 — BELLUS-Q | Speclipse, Inc. Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252762 — HALO AP Dx | Indica Labs, LLC Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251401 — PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252004 — enCore Night Guard | Encore Guards Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252253 — Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252328 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary Care Diagnostics Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253407 — NeVa PV Thrombectomy Device | Vesalio, Inc. Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252704 — F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | F Care Systems USA, LLC Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252787 — Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250769 — Dakota LP System | Precision Spine, Inc. Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251631 — The BAG manual resuscitator and accessories | Laerdal Medical AS Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252366 — a2z-Unified-Triage | A2z Radiology Ai, Inc. Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250634 — BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252509 — AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. Mon Nov 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250927 — KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG Sat Nov 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252666 — Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251293 — CardioVision | Icardio.Ai Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250700 — Pen Injector Needle 32.5 | Terumo Corporation Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | Everyway Medical Instruments Co.,Ltd Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252696 — LEGACY | Phasor Health, LLC Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251205 — Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250560 — BEE HA | NGMedical GmbH Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |