Given Imaging Ltd.FFTClass I

Electrode, Ph, Stomach

Given Imaging Ltd.'s record for this product code

MDR events10,600All time

Recalls1All time

510(k) clearances1All time

Recent MDR events

10,600 adverse event reports on file

Recalls

1 recall events for this product code

Open, ClassifiedJul 10, 2025
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
View FDA record ↗

510(k) clearances

1 clearances for this product code

K102543Dec 1, 2010
BRAVO PH MONITORING SYSTEM AND ACCESSORIES