174,693 clearances — data as of 2026-04-10
Search every FDA
medical device clearance
Instant access to 510(k) clearances, company profiles, and product codes. Built for RA professionals.
Latest clearances
most recent 12- K252207 — ABL90 FLEX PLUS System, safeCLINITUBES
- K260430 — Porcelain Etch Gel
- K260244 — Auryon Atherectomy System
- K260839 — Protaryx Transseptal Puncture Device (PTX2-001)
- K252548 — AI-Rad Companion Organs RT
- K254004 — VRNT
- K252757 — CeQur Simplicity On-Demand Insulin Delivery System
- K253510 — Freestyle Mini Hands-free
- K253361 — Teleport Glide Microcatheter
- K253689 — syngo Dynamics (VA41F)
- K253657 — Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads
- K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
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.