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 |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | Jul 2, 2026 |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | Jul 2, 2026 |
| K261867 | Xpert Carba-R | Cepheid® | Jul 2, 2026 |
| K261847 | iTero Lumina™ Pro | Align Technology , Ltd. | Jul 2, 2026 |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | Jul 2, 2026 |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC | Jul 2, 2026 |
| K261129 | OrthoFit | Spident Co., Ltd. | Jul 2, 2026 |
| K260755 | OptraSCAN System | Optrascan, Inc. | Jul 2, 2026 |
| K260596 | Collagen Wound Powder | Ventris Medical | Jul 2, 2026 |
| K260528 | OncoStudio | Oncosoft. Inc., | Jul 2, 2026 |
| K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | Jul 2, 2026 |
| K253884 | Koios DS (3.8) | Koios Medical, Inc. | Jul 2, 2026 |
| K253704 | iPredict-DR | iHealthscreen, Inc. | Jul 2, 2026 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | Jul 2, 2026 |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | Jul 2, 2026 |
| K252243 | Fastplex™ BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | Jul 2, 2026 |
| DEN250034 | Claria System | Claria Medical, Inc. | Jul 2, 2026 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | Jul 1, 2026 |
| K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | Jul 1, 2026 |
| K261852 | OTS Hip | Ortoma AB | Jul 1, 2026 |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | Jul 1, 2026 |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | Jul 1, 2026 |
| K261473 | Chromix | Termosalud S.L. | Jul 1, 2026 |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | Jul 1, 2026 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | Jul 1, 2026 |
| K261021 | EasyWhip Family | Winter Innovations, Inc. | Jul 1, 2026 |
| K260556 | Veritas Shoulder System | Restor3D | Jul 1, 2026 |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | Jul 1, 2026 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | Jul 1, 2026 |
| K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | Covidien, LLC | Jul 1, 2026 |
