| K252601 — Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) | Hunan Accurate Bio-Medical Technology Co., Ltd. May 14, 2026 |
| K254133 — ENTity USB Videoscope System | Optim, LLC May 14, 2026 |
| K253078 — ART.1-US | Seetreat Pty, Ltd. May 14, 2026 |
| K252652 — Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr | Fortis Biosolutions Company Limited May 14, 2026 |
| K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation May 13, 2026 |
| K260032 — Morph | BeauBrain Healthcare, Inc. May 13, 2026 |
| K253061 — Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. May 13, 2026 |
| K252653 — ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | Acist Medical Systems, Inc. May 13, 2026 |
| K261363 — Y-Knotless Flex Anchors | CONMED Corporation May 13, 2026 |
| K253241 — Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. May 13, 2026 |
| K252591 — Automatic Micro Needle System (CODE-X) | Woorhi Mechatronics Co., Ltd. May 13, 2026 |
| K252638 — VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | Acist Medical Systems, Inc. May 13, 2026 |
| K254073 — StatSeal Disc | Merit Medical Systems, Inc. May 13, 2026 |
| K254125 — Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. May 13, 2026 |
| K252731 — Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB May 12, 2026 |
| K260850 — OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. May 12, 2026 |
| K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. May 12, 2026 |
| K260051 — CorVision® (91-205-Z0014) | CorVent® Medical, Inc. May 12, 2026 |
| K260235 — CellDx-Tissue | Datar Cancer Genetics Private Limited May 12, 2026 |
| K261196 — Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. May 12, 2026 |
| K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) | Shenzhen Kingboom Technology Co., Ltd. May 12, 2026 |
| K260415 — myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. May 12, 2026 |
| K260837 — VersaLift Expandable System | Life Spine, Inc. May 12, 2026 |
| K260378 — Rayvolve | AZmed May 12, 2026 |
| K254192 — Senhance Ultrasonic System | Asensus Surgical May 12, 2026 |
| K252953 — Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. May 11, 2026 |
| K254228 — KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG May 11, 2026 |
| K250964 — Protable Phlegm Suction Unit (JMA D01) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. May 11, 2026 |
| K253696 — CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) | Verathon Medical (Canada) Ulc May 11, 2026 |
| K260805 — Dual Core | Vericom Co., Ltd. May 11, 2026 |
| K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) | Shenzhen Imdk Medical Technology Co., Ltd. May 11, 2026 |
| K260846 — Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. May 11, 2026 |
| K260196 — ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) | Ethicon Endo-Surgery, LLC May 11, 2026 |
| K261214 — PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. May 11, 2026 |
| K260842 — HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics May 11, 2026 |
| K252880 — Pytheas Your Guided Trajectory | Pytheas Navigation Sas May 11, 2026 |
| K254178 — SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. May 11, 2026 |
| K261145 — Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC May 9, 2026 |
| K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system | Carlsmed, Inc. May 9, 2026 |
| K260419 — LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. May 8, 2026 |
| K253013 — Disposable Stone Retrieval Balloon Catheter | Zhejiang Soudon Medical Technology Co., Ltd. May 8, 2026 |
| K252621 — DeepSkin (DEP100) | El Global Trade, Ltd. May 8, 2026 |
| K253679 — Hydro Irrigation System | Stryker Instruments May 8, 2026 |
| DEN250013 — Modius Spero | Neurovalens Limited May 8, 2026 |
| K250814 — Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | Zeus Scientific May 8, 2026 |
| K260788 — Smylio Aligners | Smylio, Inc. May 8, 2026 |
| K252617 — MiroCam® Capsule Endoscope System | Intromedic Co., Ltd. May 8, 2026 |
| K260321 — HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC May 8, 2026 |
| K260792 — AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC May 8, 2026 |
| K254215 — Arthrex Beaming System | Arthrex, Inc. May 8, 2026 |