| K250974 — Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.R.L Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250488 — Cerynë Intimate Care | Ansella Therapeutics Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251989 — VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250847 — VaporShield | Vault Paragon Group, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252120 — Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242817 — Jason membrane | Botiss Biomaterials GmbH Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252482 — CogNet AI-MT+ | Medcognetics, Inc. Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252997 — HyperFlex® Bunion Correction System | Hyperflex Medical Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253141 — DeepRhythmAI | Medicalgorithmics S.A. Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252897 — APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista | A Plus Biotechnology Co., Ltd. Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251883 — MIM LesionID Pro | Mim Software, Inc. Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250988 — KLS Martin Pure Pectus System | KLS-Martin L.P. Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252694 — Target Detachable Coil | Stryker Neurovascular Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252497 — SANSA HSAT | Huxley Medical Wed Dec 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250192 — Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. Wed Dec 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251598 — Intellidrop | Brainspace, Inc. Wed Dec 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252826 — ARIX Femur Nail System | Jeil Medical Corporation Wed Dec 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252343 — Atlantis® Abutments in Titanium | Dentsply Sirona Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253706 — Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252808 — GlasIonomer FX-LC | Shofu Dental Corporation Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243449 — INFINITT DPS | Infinitt Healthcare Co., Ltd. Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251199 — Allia Moveo | GE Medical Systems SCS Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250742 — Focused Cryotherapy System | Focused Cryo, Inc. Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251936 — Ceribell Delirium Monitor System | Ceribell, Inc. Mon Dec 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252294 — Fetal EchoScan (v1.2) | Brightheart Mon Dec 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252789 — Glass Ceramic | Shenzhen Xiangtong Co., Ltd. Mon Dec 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. Mon Dec 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251829 — DeGen Medical Patient Specific Implant (PSI) System | Degen Medical Mon Dec 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252994 — LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) | Guangdong Ace-Tec Co., Ltd. Mon Dec 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250190 — Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd Mon Dec 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252862 — Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. Mon Dec 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250795 — PUREVUE FMS | W.O.M. World of Medicine GmbH Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252841 — REAL INTELLIGENCE CORI XT (CORI XT) | Blue Belt Technologies, Inc. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250764 — SpineLinc Anterior Cervical Implant System | Lincotek Medical Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243438 — MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251731 — KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252067 — Velora Acetabular System | Restor3D, Inc. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252465 — Any-Core | Mediclus Co., Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250711 — VSP Orthopedics System | 3D Systems, Inc. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251514 — Overjet CBCT Assist | Overjet, Inc. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250512 — Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) | Sonoscape Medical Corp. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250743 — Remvia NightGuard | Remvia Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252296 — OncoPatch | Oncopatch, Inc. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |