FDA Device Intelligence
Home › Device types › ODX

Autonomous Extracorporeal Blood Leak Detector/Alarm

FDA product code ODX · Class 2 · Gastroenterology, Urology

1
Registered devices
12
Adverse events
1
Recalls
4
510(k) clearances

Devices with this code

Andorate® 4-piece Valve Kit — GA Health Company Limited

Recent recalls

DateFirmReason
2011-08-11Fresenius Medical Care Holdings, Inc.Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions

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.