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 |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | Aug 7, 2026 |
| K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | Aug 7, 2026 |
| K261905 | BUM Oil | Bumlicious, LLC (DBA “Bumlicious”) | Aug 7, 2026 |
| K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | Aug 7, 2026 |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Aug 7, 2026 |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | Aug 7, 2026 |
| K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | Aug 7, 2026 |
| K261362 | Xpert Hemorrhagic Fever | Cepheid | Aug 7, 2026 |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | Aug 7, 2026 |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Aug 7, 2026 |
| K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | Aug 7, 2026 |
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | Aug 7, 2026 |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | Aug 7, 2026 |
| K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | Aug 7, 2026 |
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | Aug 7, 2026 |
| K253505 | Zamenix™ P | Roen Surgical, Inc. | Aug 7, 2026 |
| K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | Aug 7, 2026 |
| K252571 | mdprostate | Mediaire GmbH | Aug 7, 2026 |
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | Aug 7, 2026 |
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | Aug 6, 2026 |
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Aug 6, 2026 |
| K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | Aug 6, 2026 |
| K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | Aug 6, 2026 |
| K260223 | Aristotle Mini Guidewire | Scientia Vascular, Inc. | Aug 6, 2026 |
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | Aug 6, 2026 |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | Aug 6, 2026 |
| K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | Mozarc Medical Us, LLC | Aug 6, 2026 |
| K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | Aug 6, 2026 |
| P220015 | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens | Tianjin MasterVision Technology Co., Ltd. | Aug 5, 2026 |
| K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | Aug 5, 2026 |
