176,379 clearances · FDA's latest release: October 2, 2026
Index last refreshed: October 18, 2026
Search every FDA medical device clearance
Search clearances, recalls, product codes, and companies. Predicate trees coming.
Latest clearances
View all 176,379 →- K260233 — Elecsys EBV IgM
- K260468 — H100Plus Hemoglobin Testing System
- K262412 — Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)
- K263113 — ZSAlign Cervical Interbody System
- K253422 — OAB Delivery Catheter
- K260487 — stentFIX System Set (100.50n)
- K263086 — AltiVate Reverse® Glenosphere with RAVN Technology
- K261741 — Hemostatic Clip
- K261783 — Plenity-V (MC0979 / GS110)
- K260689 — CVS Advanced PLUS Blood Glucose Monitoring System
- K260044 — Ventricular Catheters, Thomale Catheter
- K261217 — AnyPlus II Spinal Fixation System
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.