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 |
|---|---|---|---|
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | May 30, 2026 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | May 30, 2026 |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | May 29, 2026 |
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | May 29, 2026 |
| K261060 | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | May 29, 2026 |
| K261038 | Xpert PFP | Newclip Technics | May 29, 2026 |
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | INTEROJO, Inc. | May 29, 2026 |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | May 29, 2026 |
| K260262 | Injection Needle | Mirco-Tech (Nanjing) Co., Ltd. | May 29, 2026 |
| K260138 | LUNE PureHygiene | Enamel Pure | May 29, 2026 |
| K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | May 29, 2026 |
| K254300 | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited | May 29, 2026 |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | C.R. Bard, Inc. | May 29, 2026 |
| K253119 | CoSense ETCO Monitor | Capnia, Inc. | May 29, 2026 |
| K253103 | Nexus DRF Digital X-ray Imaging System | Varex Imaging Corporation | May 29, 2026 |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | May 29, 2026 |
| K252947 | HistoSonics® Planning Tool | HistoSonics, Inc. | May 29, 2026 |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | May 29, 2026 |
| K252840 | M12 Telemetry System | Global Instrumentation, LLC | May 29, 2026 |
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Böblingen GmbH | May 29, 2026 |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | May 29, 2026 |
| K252396 | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde | May 29, 2026 |
| K261405 | ANDI 2.2 | Imeka Solutions, Inc. | May 28, 2026 |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | May 28, 2026 |
| K260895 | Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. | May 28, 2026 |
| K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | May 28, 2026 |
| K260295 | Helio Kids; Apex P | Motion Composites | May 28, 2026 |
| K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | May 28, 2026 |
| K254092 | Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. | May 28, 2026 |
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | May 28, 2026 |
