FMEClass I

Gown, Examination

General Hospital · 21 CFR 880.6265

MDR events7All time

Recalls1All time

Registered firms236Currently listed

510(k) clearances5All time

Recent MDR events

7 adverse event reports on file

Event type breakdown

Injury2

Malfunction2

Other2

Death1

Most-reported manufacturers

Medline Industries, Inc.2 Unspecified1 Bd & Co.1 Becton Dickinson1 Cardinal Health1 Patientstyle Medical Llc1

Recalls

1 recall events for this product code

Encompass Group LLC
TerminatedMar 22, 2010
Thermoflect Product Line including items for adults and pediatrics.
The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.
Z-1175-2010 · View FDA record ↗

Registered firms

236 firms currently registered for this product code

510(k) clearances

5 clearances for this product code