| K250369 — Axial3D Insight | Axial Medical Printing Limited Sep 18, 2025 |
| K252428 — Electric Wheelchair (Model P2) | Superpi Robot Co., Ltd. Sep 18, 2025 |
| K251377 — Magic InBra | Medela AG Sep 18, 2025 |
| K251649 — Sunny Plus (Sunny) | ShenB Co., Ltd. Sep 18, 2025 |
| K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) | Vitacore Industries, Inc. Sep 17, 2025 |
| K252035 — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. Sep 17, 2025 |
| K252615 — Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine Sep 17, 2025 |
| K243752 — Double Tube Herbst Appliance | The Tmj Clinic PC Sep 17, 2025 |
| K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC Sep 17, 2025 |
| K251386 — ECHELON Synergy | Fujifilm Corporation Sep 17, 2025 |
| K244006 — FG Bone Graft M | Full Golden Biotech Co., Ltd. Sep 17, 2025 |
| K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC Sep 17, 2025 |
| K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott Sep 17, 2025 |
| K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation Sep 17, 2025 |
| K251623 — Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) | Shenzhen Yicai Health Technology Co., Ltd. Sep 17, 2025 |
| K242287 — SFIT Abutment | Cowellmedi Co., Ltd. Sep 16, 2025 |
| K251650 — Insight Enhanced DRF (EN-1002-01) | Imaging Engineering, LLC Sep 16, 2025 |
| K252540 — ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG Sep 16, 2025 |
| K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC Sep 16, 2025 |
| K251914 — IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) | Miley Technology (Hebei) Co., Ltd. Sep 15, 2025 |
| K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. Sep 15, 2025 |
| K250609 — Sober Self-Test | Sober Ip, LLC Sep 15, 2025 |
| K252128 — Zener® (model ZEN-001-B1) | Uvx, Inc. Sep 15, 2025 |
| K251780 — iGPS Navigation Instruments | SI-BONE, Inc. Sep 15, 2025 |
| K250237 — InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. Sep 15, 2025 |
| K251869 — Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited Sep 15, 2025 |
| K252443 — SpaceFix Shoulder Spacer | G21, S.R.L. Sep 15, 2025 |
| K250689 — CloudTMS Edge | Teleemg, LLC Sep 14, 2025 |
| K251449 — BrainsWay Deep TMS System | Brainsway , Ltd. Sep 13, 2025 |
| K243864 — BONX805 | Bontech Co., Ltd. Sep 12, 2025 |
| K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | Becton, Dickinson And Company Sep 12, 2025 |
| K252554 — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | Vivachek Biotech (Hangzhou) Co., Ltd. Sep 12, 2025 |
| K252595 — Stethophone Pro | Sparrow Acoustics, Inc. Sep 12, 2025 |
| K252225 — PowerKnot High Strength Sutures | Medacta International S.A. Sep 12, 2025 |
| K251820 — ViewMateTM Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Sep 12, 2025 |
| K252586 — CADDIE | Odin Medical Limited Sep 12, 2025 |
| K252027 — Vertex(TM) Catheter | Jupiter Endovascular Sep 12, 2025 |
| K250040 — uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. Sep 12, 2025 |
| K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. Sep 12, 2025 |
| K250047 — bite away two | mibeTec GmbH Sep 12, 2025 |
| K252576 — Legend X Platform | Pollogen, Ltd. Sep 12, 2025 |
| K252189 — LED Light Therapy Mask (2311, 2344, 2457, 2458) | Dongguan Yanxi Technology Co., Ltd. Sep 12, 2025 |
| K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | Tangent Endoscopy, LLC Sep 12, 2025 |
| K250445 — Fast Warm - NX | Fujifilm Irvine Scientific Sep 12, 2025 |
| K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation Sep 12, 2025 |
| K252562 — Spine & Trauma Navigation Instruments | Brainlab AG Sep 12, 2025 |
| K250628 — DynaNail TTC Fusion System | MedShape, Inc. Sep 12, 2025 |
| K251083 — Compact II | Enraf-Nonius, B.V. Sep 12, 2025 |
| K251518 — Volta AF-Xplorer II | Volta Medical Sep 12, 2025 |
| K251368 — FETOLY | Diagnoly Sep 12, 2025 |