175,825 clearances · FDA's latest release: August 7, 2026
Index last refreshed: August 20, 2026
Search every FDA medical device clearance
Search clearances, recalls, product codes, and companies. Predicate trees coming.
Latest clearances
View all 175,825 →- K260567 — EW10-EC02 Endoscopy Support Program
- K261563 — Freedom Total Knee System (E-Poly Tibial Liners)
- K261668 — Venue Go
- K262357 — Arthrex Bioabsorbable PushLock Suture Anchors
- K261937 — PacTemp Automix NE
- K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
- 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)
- K253561 — Aperio iQC DX Software
- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K253554 — Aperio GT 450 DX; Aperio GT 180 DX
- K261362 — Xpert Hemorrhagic Fever
- K253453 — Metrix COVID Test; Metrix COVID Test Pro
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.