| K260428 — RIVOS EUS Access Device (M00553900) | Boston Scientific Corporation Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261672 — twiist Automated Insulin Delivery (AID) System | Deka Research and Development Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252399 — Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253045 — Socko Vimax Spinal Fixation System | Socko Medical Co., Ltd. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253231 — Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) | Hubei Yjt Technology Co.,Ltd Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253159 — Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253374 — LimiFlex® Dynamic Sagittal Tether Instrument Set | Empirical Spine Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253723 — BOSS | Medpark Co., Ltd. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253069 — Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek, Inc. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254025 — LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Fujifilm Corporation Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260899 — Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Zdeer Technology (Henan) Co., Ltd. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253046 — HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260831 — Z1 Hip System | Zimmer, Inc. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260844 — ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253264 — myAblation Guide (VC10A) | Siemens Healthcare GmbH Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260693 — VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261833 — NEUROMARK System (NMK00301) | Neurent Medical , Ltd. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261683 — Augment Off-Axis Instrument System | Zimmer, Inc. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253001 — KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260036 — NeckTune 3D SA Cervical Cage | Medyssey Co, Ltd. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253059 — Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261265 — Permatage XT Settable Bone Putty | Orthocon, Inc. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260300 — WatchMate Software | Anumana, Inc. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260482 — DRE Duo | Jpi Healthcare Co, Ltd. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260286 — Dynamo Spinal Cement; Salvo® Spine System | Spine Wave, Inc. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253690 — LungMaps | Siemens Healthineers AG Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260335 — Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253922 — Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253172 — MediAI-OA | Crescom Co., Ltd. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260885 — VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260126 — Curajel Oral Gel | USpharma, Ltd. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253825 — Saige-Dx | DeepHealth, Inc. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253151 — Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253121 — Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Gimbo Medical Technology Shenzhen Co., Ltd. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC Mon Jun 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. Sat Jun 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261213 — Medical Monitor (40HT513D) | Lg Electronics.Inc Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261634 — Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252171 — Barbed PDO Suture | Sutura Medical Technology, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253088 — OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252933 — DYNE PORT | Dyne Medical Group, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260346 — Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260935 — Stelo Glucose Biosensor System | Dexcom, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260635 — HARBOR Occlusion Device | Nuvascular, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253437 — Spiro-VISTA | Spiro Robotics Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |