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 |
|---|---|---|---|
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | May 16, 2026 |
| P260004 | Signatera CDx | Natera, Inc. | May 15, 2026 |
| K261289 | UNiD Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | May 15, 2026 |
| K261273 | Neurophet AQUA | Neurophet., Inc. | May 15, 2026 |
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+ | Bausch and Lomb | May 15, 2026 |
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | May 15, 2026 |
| K260771 | TruSelect 2.6 Microcatheter | Boston Scientific Corporation | May 15, 2026 |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | Depuy Ireland UC | May 15, 2026 |
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | May 15, 2026 |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) | Shenzhen Root Innovation Technology Co., Ltd. | May 15, 2026 |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) | Hycor Biomedical | May 15, 2026 |
| K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | May 15, 2026 |
| K254050 | Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | May 15, 2026 |
| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) | Sonoscape Medical Corp. | May 15, 2026 |
| K253935 | medXion NEXUS | medXion Technologies, Inc. | May 15, 2026 |
| K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | May 15, 2026 |
| K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | May 15, 2026 |
| K253716 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super | Wuhan United Imaging Healthcare Co.,Ltd | May 15, 2026 |
| K253642 | Jada System (Jada-2002) | Organon, LLC | May 15, 2026 |
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | May 15, 2026 |
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | May 15, 2026 |
| K252624 | KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | May 15, 2026 |
| K252563 | Neurophet SCALE PET | Neurophet., Inc. | May 15, 2026 |
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | May 15, 2026 |
| K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | May 15, 2026 |
| K250781 | Embryo Predict | Alife Health | May 15, 2026 |
| K261317 | BriefCase-Triage | Aidoc Medical , Ltd. | May 14, 2026 |
| K261241 | TriMed Compression Screws | TriMed, Inc. | May 14, 2026 |
| K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | May 14, 2026 |
| K261134 | Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, Inc. | May 14, 2026 |
