176,013 clearances · FDA's latest release: August 28, 2026
Index last refreshed: September 11, 2026
Search every FDA medical device clearance
Search clearances, recalls, product codes, and companies. Predicate trees coming.
Latest clearances
View all 176,013 →- K261378 — Rayvolve AZchest
- K260203 — Fule Vertebroplasty Balloon Catheter
- K253954 — X-Guide Surgical Navigation System
- K261176 — Zoom 4S Catheter
- K260517 — Automatic Core Biopsy Instrument
- K261582 — Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
- K254261 — Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)
- K253630 — Mpact 3D Metal Foam
- K260617 — Tigertriever 13 Ultra Revascularization Device
- K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more
- K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
- K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more
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.