FGMClass I

Probe And Director, Gastro-urology

Gastroenterology, Urology · 21 CFR 876.4730

MDR events20All time

Recalls1All time

Registered firms105Currently listed

510(k) clearances7All time

Recent MDR events

20 adverse event reports on file

Event type breakdown

Malfunction11

Injury4

Unspecified2

Other2

Death1

Most-reported manufacturers

Everest Medical3 Olympus Optical Co. Ltd.2 Allegiance Healthcare Corp.1 Boston Scientific1 Carefusion1 Hewlett-packard Company1 Integra York, Pa Inc.1 Karl Star Endoscopy-america1

Recalls

1 recall events for this product code

Medtronic Gastroenterology / Urology
TerminatedJul 20, 2004
Bravo pH Monitoring System Receiver
The product's rear panel label could smear during use causing the serial number to be unreadible. This has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.
Z-0633-04 · View FDA record ↗

Registered firms

105 firms currently registered for this product code

510(k) clearances

7 clearances for this product code