| K261370 — LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. Sep 16, 2026 |
| K262054 — Electric Wheelchair | Yongkang Joymax Medical Technology Co., Ltd. Sep 16, 2026 |
| K261400 — Ambu® aScope Gastro; Ambu® aScope Gastro Large | Ambu A/S Sep 16, 2026 |
| K261283 — APERTO Lucent MRI System | Fujifilm Corporation Sep 16, 2026 |
| K254212 — NC PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. Sep 16, 2026 |
| K261623 — EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound And Primary Care Diagnostics Sep 16, 2026 |
| K261778 — JADE SCORE PTA Scoring Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. Sep 16, 2026 |
| K260309 — Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S Sep 16, 2026 |
| K261467 — GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | Gt Metabolic Solutions, Inc. Sep 16, 2026 |
| K261865 — AerFrame Alignment Laser Box (LBV2) | Stabilix, LLC Sep 16, 2026 |
| K261758 — Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. Sep 16, 2026 |
| K254152 — Dia-X Sil Light Body | DiaDent Group International Sep 16, 2026 |
| K261896 — iOS CamAPS FX | CamDiab Sep 16, 2026 |
| K260220 — Route 92 Medical Full Length 046 Access System | Route 92 Medical, Inc. Sep 16, 2026 |
| K262057 — GMK Extension | Medacta International SA Sep 15, 2026 |
| K261447 — CVAC® Aspiration System | Calyxo, Inc. Sep 15, 2026 |
| K260141 — Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | Zhenjiang Assure Medical Equipment Co., Ltd. Sep 15, 2026 |
| K261861 — SPINEsim v1.0 | Mdsim S.A. Sep 15, 2026 |
| K254214 — OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. Sep 15, 2026 |
| K261677 — Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC Sep 15, 2026 |
| K260144 — Reclining wheelchair (YJ-013L) | Zhenjiang Assure Medical Equipment Co., Ltd. Sep 15, 2026 |
| K260446 — Tontarra Punches and Rongeurs | Tontarra Medizintechnik GmbH Sep 15, 2026 |
| K262963 — TMC Implant Fixation System | Treace Medical Concepts, Inc. Sep 15, 2026 |
| K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC Sep 15, 2026 |
| K260145 — YJ-K1K2 Wheelchair (YJ-013F) | Zhenjiang Assure Medical Equipment Co., Ltd. Sep 15, 2026 |
| K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | Maduro Medical, Inc. Sep 14, 2026 |
| K262163 — BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | Becton Dickinson And Company Sep 14, 2026 |
| K253481 — colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Ovesco Endoscopy AG Sep 14, 2026 |
| K260781 — Yumizen H550 | HORIBA ABX SAS Sep 14, 2026 |
| K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | Xenix Medical Sep 14, 2026 |
| K260795 — Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. Sep 14, 2026 |
| K261517 — qCT Lung (v1.0) | Qure.Ai Technologies Pvt. , Ltd. Sep 14, 2026 |
| K261438 — HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | Eurosets S.R.L Sep 14, 2026 |
| K262526 — Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. Sep 13, 2026 |
| K260133 — CADDIE | Odin Medical Limited Sep 12, 2026 |
| K261287 — Digistat Care | Ascom Ums Srl Unipersonale Sep 12, 2026 |
| K262861 — PureLift Pro Max | Xtreem Pulse, LLC Sep 11, 2026 |
| K254119 — Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) | Shenzhen Xinyan Medical Technology Co.,Ltd. Sep 11, 2026 |
| K262151 — SpaceOAR Flex System | Boston Scientific Corporation Sep 11, 2026 |
| K262397 — CuratOR EX2742 | Eizo Corporation Sep 11, 2026 |
| K261019 — ANTERION | Heidelberg Engineering GmbH Sep 11, 2026 |
| K254072 — BoneVue | Curvebeam AI / Curvebeam, LLC Sep 11, 2026 |
| K254177 — Disposable Sterile Skull Drill (LZ) | Guizhou Zirui Technology Co., Ltd. Sep 11, 2026 |
| K262050 — Vioseal X | Spident Co., Ltd. Sep 11, 2026 |
| K262874 — CraniUS Plate | CraniUS, LLC Sep 11, 2026 |
| K262230 — Mg OSTEOREVIVE;Mg OSTEOCRETE | Bone Solutions, Inc. Sep 11, 2026 |
| K260001 — Mint ACE Pump | Beta Bionics, Inc. Sep 11, 2026 |
| K254041 — SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC Sep 11, 2026 |
| K261580 — ZBPro Diagnostic (Version 2.0) | Zbeats, Inc. Sep 11, 2026 |
| K261305 — MICSI-PET | Microstructure Imaging, Inc. Sep 11, 2026 |