FCPClass I

Box, Battery, Pocket

Gastroenterology, Urology · 21 CFR 876.1500

MDR events2All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances2All time

Recent MDR events

2 adverse event reports on file

Event type breakdown

Malfunction1

Other1

Most-reported manufacturers

St Jude Medical1 Unipower Corporation1

Recalls

1 recall events for this product code

EXP Pharmaceutical Services Corp
TerminatedJul 24, 2015
Medical Device Exchange -APPLIER, MULTICLIP ROTATING;
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Z-2226-2015 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

510(k) clearances

2 clearances for this product code