FDA Device Intelligence
HomeSTERIS CORPORATION › AQUALGEL

AQUALGEL

STERIS CORPORATION · Model BF486 · UDI-DI 00724995219987

LWG
4
510(k) clearances
34
Adverse events
1
Recalls
59
Facilities

Description

Large AQUAGEL Supine Package contains the Oasis full length table pad, the Elite Supine Headrest (adult), Long Arm Protector, Sacral Protector and Leg Protector.

Recalls

DateFirmReason
2016-04-19Berchtold Corp.The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-r

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.