| K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek, Inc. Jun 16, 2026 |
| K254025 — LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Jun 16, 2026 |
| K261683 — Augment Off-Axis Instrument System | Zimmer, Inc. Jun 16, 2026 |
| K253374 — LimiFlex® Dynamic Sagittal Tether Instrument Set | Empirical Spine Jun 16, 2026 |
| K260899 — Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Zdeer Technology (Henan) Co., Ltd. Jun 16, 2026 |
| K253001 — KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. Jun 16, 2026 |
| K260958 — I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH Jun 16, 2026 |
| K260036 — NeckTune 3D SA Cervical Cage | Medyssey Co, Ltd. Jun 15, 2026 |
| K253172 — MediAI-OA | Crescom Co., Ltd. Jun 15, 2026 |
| K253059 — Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. Jun 15, 2026 |
| K253121 — Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Gimbo Medical Technology Shenzhen Co., Ltd. Jun 15, 2026 |
| K261265 — Permatage XT Settable Bone Putty | Orthocon, Inc. Jun 15, 2026 |
| K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC Jun 15, 2026 |
| K260885 — VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited Jun 15, 2026 |
| K260452 — Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | Zdeer Technology (Henan) Co., Ltd. Jun 15, 2026 |
| K253151 — Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. Jun 15, 2026 |
| K253690 — LungMaps | Siemens Healthineers AG Jun 15, 2026 |
| K260482 — DRE Duo | Jpi Healthcare Co, Ltd. Jun 15, 2026 |
| K260126 — Curajel Oral Gel | USpharma, Ltd. Jun 15, 2026 |
| K260335 — Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. Jun 15, 2026 |
| K253922 — Neodent Scannable Healing Abutment | JJGC Indústria E Comércio De Materiais Dentários S.A. Jun 15, 2026 |
| K260286 — Dynamo Spinal Cement; Salvo® Spine System | Spine Wave, Inc. Jun 15, 2026 |
| K253825 — Saige-Dx | DeepHealth, Inc. Jun 15, 2026 |
| K260300 — WatchMate Software | Anumana, Inc. Jun 15, 2026 |
| K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. Jun 13, 2026 |
| K253437 — Spiro-VISTA | Spiro Robotics Jun 12, 2026 |
| K261366 — Virtus | Somnomed, Inc. Jun 12, 2026 |
| K252933 — DYNE PORT | Dyne Medical Group, Inc. Jun 12, 2026 |
| K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. Jun 12, 2026 |
| K253088 — OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. Jun 12, 2026 |
| K253015 — Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. Jun 12, 2026 |
| K253688 — MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. Jun 12, 2026 |
| K261207 — Exalta Proximal Tibia Plating System | Tyber Medical, LLC Jun 12, 2026 |
| K252963 — BTL-899TT | BTL Industries, Inc. Jun 12, 2026 |
| K261213 — Medical Monitor (40HT513D) | Lg Electronics.Inc Jun 12, 2026 |
| K252987 — ADRx Admixture Device | Epic Medical Pte. , Ltd. Jun 12, 2026 |
| K260406 — Brainomix 360 Hyperdensity | Brainomix Limited Jun 12, 2026 |
| K252932 — Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated Jun 12, 2026 |
| K261634 — Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. Jun 12, 2026 |
| K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) Jun 12, 2026 |
| K252323 — cobas pulse blood glucose monitoring system | Roche Diagnostics Jun 12, 2026 |
| K260346 — Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited Jun 12, 2026 |
| K261204 — Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. Jun 12, 2026 |
| K260935 — Stelo Glucose Biosensor System | Dexcom, Inc. Jun 12, 2026 |
| K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation Jun 12, 2026 |
| K261175 — WHILL (WHILL Model C2) | Whill, Inc. Jun 12, 2026 |
| K252996 — Universal 1417PI | Konica Minolta Healthcare Americas, Inc. Jun 12, 2026 |
| K252171 — Barbed PDO Suture | Sutura Medical Technology, Inc. Jun 12, 2026 |
| K260635 — HARBOR Occlusion Device | Nuvascular, Inc. Jun 12, 2026 |
| K252937 — ThinkQA 3 | Dosisoft SA Jun 12, 2026 |