| K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. Sep 19, 2025 |
| K252647 — Tapestry Biointegrative Implant | Embody, Inc. Sep 19, 2025 |
| K250777 — Sonicaid Team3 | Huntleigh Healthcare , Ltd. Sep 19, 2025 |
| DEN240067 — KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited Sep 19, 2025 |
| K252662 — UniBur | Nakanishi, Inc. Sep 19, 2025 |
| K251167 — uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. Sep 19, 2025 |
| K250450 — Coated hip implants | Medacta International S.A. Sep 19, 2025 |
| K242859 — VEGA | Ibramed Equipamentos Médicos Sep 19, 2025 |
| K244035 — Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. Sep 19, 2025 |
| K250128 — Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. Sep 19, 2025 |
| K250953 — EQUIA LC ONE | GC America, Inc. Sep 19, 2025 |
| K251100 — IPGTFL-02 | Ipg Medical Corporation Sep 19, 2025 |
| K243990 — BondEase 2 Topical Skin Adhesive | Optmed, Inc. Sep 19, 2025 |
| K250408 — Alegria Flash ENA Screen | Zeus Scientific Sep 19, 2025 |
| K252657 — Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. Sep 19, 2025 |
| K252285 — Well-Root PT | Vericom Co., Ltd. Sep 19, 2025 |
| K250649 — Bunkerhill ECG-EF | BunkerHill Health Sep 19, 2025 |
| K251002 — Videa Dental AI | Videahealth, Inc. Sep 19, 2025 |
| K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation Sep 18, 2025 |
| K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC Sep 18, 2025 |
| K251905 — Normatec Elite Hip | NormaTec Industries, LP Sep 18, 2025 |
| K251597 — InnerView System | Perimetrics, Inc. Sep 18, 2025 |
| 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 |