LWGClass I

Surgical Table Cushion

General, Plastic Surgery · 21 CFR 878.4950

MDR events34All time

Recalls1All time

Registered firms60Currently listed

510(k) clearances4All time

Recent MDR events

34 adverse event reports on file

Event type breakdown

Malfunction29

Injury3

Unspecified1

Other1

Most-reported manufacturers

Steris Corporation25 Djo, Llc1 Getinge Usa, Inc., F.k.a. Mdt Diagnostic Co.1 Holger Ullrich1 Medline Industries, Inc1 Medline Industries, Inc.1 Medline Industries, Lp1 Medtronic Neuromodulation1

Recalls

1 recall events for this product code

Berchtold Corp.
TerminatedJun 7, 2016
Surgical Table Cushion (HybriGel Pads)
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-ray.
Z-1925-2016 · View FDA record ↗

Registered firms

60 firms currently registered for this product code

510(k) clearances

4 clearances for this product code