FDA 510(k) Search and Medical Device Explorer
Search and browse FDA-cleared medical devices, 510(k) submissions, De Novo classifications, PMA records, product codes, review panels, and 21 CFR regulation groupings.
Review Panels
- Anesthesiology (AN)
- Clinical Chemistry (CH)
- Cardiovascular (CV)
- Dental (DE)
- Ear, Nose, Throat (EN)
- Gastroenterology, Urology (GU)
- Hematology (HE)
- General Hospital (HO)
- Immunology (IM)
- Medical Genetics (MG)
- Microbiology (MI)
- Neurology (NE)
- Obstetrics/Gynecology (OB)
- Ophthalmic (OP)
- Orthopedic (OR)
- Pathology (PA)
- Physical Medicine (PM)
- Radiology (RA)
- General, Plastic Surgery (SU)
- Clinical Toxicology (TX)
Recent Decisions
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations | Apr 26, 2026 |
| K261043 | AUTOBAHN Nailing System | Globus Medical, Inc. | 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 |
| K260993 | Amplatzer TorqVue Delivery System | Abbott | Apr 24, 2026 |
| K260988 | °M Warmer System with °M Station | Mequ A/S | 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 |
| K260599 | INDIGO® Aspiration System INDIGO Link | Penumbra, Inc. | Apr 24, 2026 |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | Apr 24, 2026 |
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | Apr 24, 2026 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | Apr 24, 2026 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | Apr 24, 2026 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | Apr 24, 2026 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | Apr 24, 2026 |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | Apr 24, 2026 |
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | Apr 24, 2026 |
| K253805 | Knee+ | Pixee Medical S.A.S. | 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 |
| K252810 | FloPatch FP120 | Flosonics Medical | Apr 24, 2026 |
| K252492 | Visualized Access and Delivery Catheter; PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | Apr 24, 2026 |
| K252451 | EPORE® XO cup system | Implantcast GmbH | Apr 24, 2026 |
| K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | Apr 24, 2026 |
| K252337 | EdgeFlow Gel Pad | Edgecare, Inc. | Apr 24, 2026 |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Diazyme Laboratories, Inc. | Apr 24, 2026 |
| K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | Apr 24, 2026 |
| K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | Apr 24, 2026 |
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | Apr 24, 2026 |
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | Apr 23, 2026 |
| K260976 | NeuroBlate System | Monteris Medical | Apr 23, 2026 |
| K260947 | 0.55T 12Ch Breast Coil | Neocoil, LLC | Apr 23, 2026 |
