| K252628 — CASSIE | Wesper, Inc. Apr 27, 2026 |
| K252748 — Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. Apr 27, 2026 |
| K261357 — Grandio disc multicolor | Voco GmbH Apr 27, 2026 |
| K261356 — Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. Apr 27, 2026 |
| K253658 — STA Satellite Max® | Diagnostica Stago, Inc. Apr 27, 2026 |
| K260182 — Avenir® Müller Stem; Avenir Complete Hip System | Zimmer, Inc. Apr 27, 2026 |
| K253580 — Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations Apr 26, 2026 |
| K252451 — EPORE® XO cup system | Implantcast GmbH Apr 24, 2026 |
| K250234 — SMARTeZ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. Apr 24, 2026 |
| 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 Apr 24, 2026 |
| K253805 — Knee+ | Pixee Medical S.A.S. Apr 24, 2026 |
| K260599 — INDIGO® Aspiration System INDIGO Link | Penumbra, Inc. Apr 24, 2026 |
| K252431 — Elecsys Calcitonin | Roche Diagnostics GmbH Apr 24, 2026 |
| K260228 — POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG Apr 24, 2026 |
| 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 Apr 24, 2026 |
| K260999 — LoFric Elle Pro | Wellspect AB Apr 24, 2026 |
| K260411 — PC Fix System | Chest Wall Innovations, Inc. Apr 24, 2026 |
| K252336 — Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Diazyme Laboratories, Inc. Apr 24, 2026 |
| K260988 — °M Warmer System with °M Station | Mequ A/S Apr 24, 2026 |
| K260429 — Control-IQ+ technology | Tandem Diabetes Care, Inc. Apr 24, 2026 |
| K250349 — Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. Apr 24, 2026 |
| K253459 — OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | ABBOTT MEDICAL Apr 24, 2026 |
| K250242 — Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. Apr 24, 2026 |
| K260009 — LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. Apr 24, 2026 |
| K260054 — I.T.S. PRS Phoenix II | I.T.S. GmbH Apr 24, 2026 |
| K252810 — FloPatch FP120 | Flosonics Medical Apr 24, 2026 |
| K254173 — ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. Apr 24, 2026 |
| K261043 — AUTOBAHN Nailing System | Globus Medical, Inc. Apr 24, 2026 |
| K260993 — Amplatzer TorqVue Delivery System | Abbott Apr 24, 2026 |
| K253832 — Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. Apr 24, 2026 |
| K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. Apr 24, 2026 |
| K252492 — Visualized Access and Delivery Catheter; PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. Apr 24, 2026 |
| K252337 — EdgeFlow Gel Pad | Edgecare, Inc. Apr 24, 2026 |
| K260320 — Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. Apr 23, 2026 |
| K261012 — OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. Apr 23, 2026 |
| K253752 — ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. Apr 23, 2026 |
| K254237 — CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. Apr 23, 2026 |
| K252815 — ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. Apr 23, 2026 |
| K260976 — NeuroBlate System | Monteris Medical Apr 23, 2026 |
| K253589 — Liberant RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. Apr 23, 2026 |
| K254248 — Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. Apr 23, 2026 |
| K252389 — Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. Apr 23, 2026 |
| K260152 — Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. Apr 23, 2026 |
| K260785 — DS Core CBCT Anatomy | Dentsply Sirona Apr 23, 2026 |
| K260947 — 0.55T 12Ch Breast Coil | Neocoil, LLC Apr 23, 2026 |
| K252407 — OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC Apr 23, 2026 |
| K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Medtronic, Inc. Apr 23, 2026 |
| K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Olympus Medical Systems Corp. Apr 23, 2026 |
| K252436 — Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. Apr 23, 2026 |
| K260239 — Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. Apr 22, 2026 |