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 |
|---|---|---|---|
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | Apr 17, 2026 |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | Apr 17, 2026 |
| K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | Apr 17, 2026 |
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | Apr 17, 2026 |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | Apr 17, 2026 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | Apr 17, 2026 |
| K253970 | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | Apr 17, 2026 |
| K252945 | Novasight Hybrid System | Conavi Medical, Inc. | Apr 17, 2026 |
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | Apr 17, 2026 |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag | Apr 17, 2026 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | Apr 17, 2026 |
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | Apr 17, 2026 |
| DEN250033 | XplantR Explant Tool | Hjarta Care, LLC | Apr 17, 2026 |
| K260903 | Hot Pink Pad Warming System | Xodus Medical, Inc. | Apr 16, 2026 |
| K260020 | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | Apr 16, 2026 |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | Apr 16, 2026 |
| K254274 | ARx® SAI Implant System | Life Spine, Inc. | Apr 16, 2026 |
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | Apr 16, 2026 |
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | Apr 16, 2026 |
| K254216 | Enso for Migraine | Hinge Health, Inc. | Apr 16, 2026 |
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | Apr 16, 2026 |
| K253907 | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | Apr 16, 2026 |
| K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, | Strauss Surgical USA | Apr 16, 2026 |
| K253804 | DESS Dental Smart Solutions | Terrats Medical SL | Apr 16, 2026 |
| K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) | Bright Uro, Inc. | Apr 16, 2026 |
| K253523 | Freedom DS Decompression System | Spinal Simplicity | Apr 16, 2026 |
| K253260 | ORIO-3D Cage System | SpineCraft | Apr 16, 2026 |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Apr 16, 2026 |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. | Apr 16, 2026 |
| K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | Apr 16, 2026 |
