| K260121 — Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252464 — Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253940 — M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252424 — Anti-HCV Next | Abbott Laboratories Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253243 — Cardinal Health Poly Reinforced Surgical Gown | Cardinal Health 200, LLC Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260260 — Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) | Dolanvy (Suzhou) Medical Technology Co., Ltd. Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252501 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co. , Ltd. Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | Guangzhou Wondfo Biotech Co., Ltd. Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260194 — Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260248 — Ultra-Fast Warm | Kitazato Corporation Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260660 — SABER-C System | Elevation Spine Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252409 — TearCare MGX System | Sight Sciences, Inc. Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252748 — Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261032 — NovoKnee (SteriKnee) | NovoSource Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260182 — Avenir® Müller Stem; Avenir Complete Hip System | Zimmer, Inc. Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252445 — Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261357 — Grandio disc multicolor | Voco GmbH Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261356 — Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253658 — STA Satellite Max® | Diagnostica Stago, Inc. Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252628 — CASSIE | Wesper, Inc. Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253580 — Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations Sun Apr 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260982 — Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) | Applied Medical Resources Corporation Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252336 — Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Diazyme Laboratories, Inc. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261043 — AUTOBAHN Nailing System | Globus Medical, Inc. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250242 — Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252492 — Visualized Access and Delivery Catheter; PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253805 — Knee+ | Pixee Medical S.A.S. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260228 — POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260993 — Amplatzer TorqVue Delivery System | Abbott Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250349 — Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260988 — °M Warmer System with °M Station | Mequ A/S Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260599 — INDIGO® Aspiration System INDIGO Link | Penumbra, Inc. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260429 — Control-IQ+ technology | Tandem Diabetes Care, Inc. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260411 — PC Fix System | Chest Wall Innovations, Inc. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252451 — EPORE® XO cup system | Implantcast GmbH Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253832 — Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252337 — EdgeFlow Gel Pad | Edgecare, Inc. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253459 — OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | ABBOTT MEDICAL Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252431 — Elecsys Calcitonin | Roche Diagnostics GmbH Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254173 — ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute | Stryker Spine Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260009 — LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260999 — LoFric Elle Pro | Wellspect AB Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252810 — FloPatch FP120 | Flosonics Medical Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260054 — I.T.S. PRS Phoenix II | I.T.S. GmbH Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250234 — SMARTeZ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252436 — Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252407 — OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |