FDA Device Intelligence
Home › A-DEC, INC. › A-dec

A-dec

A-DEC, INC. · Model 561R · UDI-DI 10194665007249

EBR
3
510(k) clearances
5
Adverse events
3
Recalls
72
Facilities

Description

A-dec 561R Support System,Certified Pre-Owned

Recalls

DateFirmReason
2004-04-13Busse Hospital DisposablesFirm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a sl
2004-04-13Busse Hospital DisposablesFirm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a sl
2004-04-13Busse Hospital DisposablesFirm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a sl

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
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.