176,428 clearances · FDA's latest release: October 11, 2026
Index last refreshed: October 26, 2026
Search every FDA medical device clearance
Search clearances, recalls, product codes, and companies. Predicate trees coming.
Latest clearances
View all 176,428 →- K253717 — Helo Return
- K261234 — The D-Tip Denudation Pipette
- K262902 — ECHELON Synergy
- K260080 — Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
- K260913 — CMF Titanium Splints
- K263154 — CarboClear® Cervical Navigated Instruments
- K260096 — Wishbone HAE
- K261649 — Excelsior Reach Microcatheter
- K261521 — Sleep Analysis Module
- K260687 — VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more
- K262834 — Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)
- K262301 — Rapid ICH (v4.0)
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.