175,572 clearances · FDA's latest release: July 10, 2026
Index last refreshed: July 27, 2026
Search every FDA medical device clearance
Search clearances, recalls, product codes, and companies. Predicate trees coming.
Latest clearances
View all 175,572 →- K261149 — Electric Wheelchair (DY611A-2, DY612A-1)
- K253480 — Capenergy C Equipments RF C200 and C400 Drakarian
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K261306 — AI Contouring (VA10A)
- K260880 — SedLine Sedation Monitor
- K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test
- K261031 — POSEIDON ST
- K261624 — Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component
- K254037 — LungFlow Airway Catheter
- K253670 — SmartCT (R3.0 (L10))
- K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA
- K262120 — Avara Viewer
Guides
- How 510(k) Clearance Works
Substantial equivalence, review timelines, the difference between clearance and approval.
- Understanding Predicate Devices
The legal backbone of every 510(k). Chains, reference devices, why they matter.
- Reading an FDA Recall Notice
Classes, lifecycle, fields worth reading first, and the common terminology mistakes.