FDA Device Intelligence
HomeDevice types › NDA

Helmet, Cranial, For Protective Use

FDA product code NDA · Class 1 · Physical Medicine

1
Registered devices
1
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2006-12-11Biomet 3i, LLCHealing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper s

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.