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 |
|---|---|---|---|
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | Vivachek Biotech (Hangzhou) Co., Ltd. | May 22, 2026 |
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | Senzime AB | May 22, 2026 |
| K260695 | da Vinci Firefly Imaging System | Intuitive Surgical | May 22, 2026 |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | May 22, 2026 |
| K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | May 22, 2026 |
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | May 22, 2026 |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | May 22, 2026 |
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | May 22, 2026 |
| K254137 | InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd. | May 22, 2026 |
| K254129 | Spectrum-2 | Neko Health AB | May 22, 2026 |
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 | CHISON Medical Technologies Co., Ltd. | May 22, 2026 |
| K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong | Taizhou Huangyan Guanhong Plastic Steel Products Factory | May 22, 2026 |
| K253569 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | May 22, 2026 |
| K253359 | Zenith Distal Access Long Sheath | Suzhou Zenith Vascular SciTech Limited | May 22, 2026 |
| K253060 | Sterile Latex Powder Free Surgical Gloves | Protect Gloves Company Limited | May 22, 2026 |
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. | May 22, 2026 |
| K252915 | AiSteth® | Ai Health Highway India Pvt., Ltd. | May 22, 2026 |
| K252887 | DePuy ATTUNE Knee System | DePuy Orthopaedics, Inc. | May 22, 2026 |
| K252784 | eXaSkin Plus | Anatomical Geometry S.L. | May 22, 2026 |
| K252772 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | May 22, 2026 |
| K252735 | C-beam | Pulmera, Inc. | May 22, 2026 |
| DEN250057 | PCWP Analysis Software | Cardiosense, Inc. | May 22, 2026 |
| K261359 | Stelo Glucose Biosensor System | Dexcom, Inc. | May 21, 2026 |
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Shenzhen Ulike Smart Electronics Co., Ltd. | May 21, 2026 |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | Siemens Medical Solutions USA, Inc. | May 21, 2026 |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | May 21, 2026 |
| K260962 | Sphincterotome | Taewoong Medical Co., Ltd. | May 21, 2026 |
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | Olympus Winter & Ibe GmbH | May 21, 2026 |
| K260618 | Ulthera® System | Ulthera, Inc. | May 21, 2026 |
| K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | May 21, 2026 |
