10,000 results
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53ms
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Sources: EU EUDAMED, US FDA
GIVEN IMAGING LTD.
FDA registration
GIVEN IMAGING LTD.·6 products·🇮🇱 Israel
Given Imaging Vietnam Co., Ltd.
FDA registration
Given Imaging Vietnam Co., Ltd.·4 products·🇻🇳 Vietnam
BRAVO PH MONITORING SYSTEM
FDA Adverse Event
Injury
·GIVEN IMAGING, LTD·Product code FFT·January 19, 2012
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
FDA Enforcement
Class I
·Ongoing·Given Imaging Ltd.·July 16, 2025
Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).
FDA Recall
Terminated
·Given Imaging Ltd.·Product code NEZ·March 8, 2011
Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313). Product Usage: The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry.
FDA Recall
Terminated
·Given Imaging Ltd.·Product code LLT·January 11, 2012
BRAVO CF REFLUX CAPSULE DELIVERY
FDA Adverse Event
Injury
·GIVEN IMAGING INC. / GIVEN IMAGING LTD.·Product code FFT·November 7, 2025
BRAVO CF REFLUX CAPSULE DELIVERY
FDA Adverse Event
Injury
·GIVEN IMAGING INC. / GIVEN IMAGING LTD.·Product code FFT·November 6, 2025
BRAVO CF REFLUX CAPSULE DELIVERY
FDA Adverse Event
Injury
·GIVEN IMAGING INC. / GIVEN IMAGING LTD.·Product code FFT·November 6, 2025
BRAVO CF REFLUX CAPSULE DELIVERY
FDA Adverse Event
Injury
·GIVEN IMAGING INC. / GIVEN IMAGING LTD.·Product code FFT·November 6, 2025
BRAVO CF CAPSULE
FDA Adverse Event
Injury
·GIVEN IMAGING LTD./GIVEN IMAGING INC.·Product code FFT·November 10, 2025
BRAVO PH CAPSULE DELIEVERY DEV, 1- PK
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD·Product code FFT·November 9, 2016
PILLCAM SB3 CAPSULE
FDA Adverse Event
Injury
·GIVEN IMAGING LTD.·Product code NEZ·August 12, 2015
BRAVO PH CAPSULE DELIVERY DEVICE
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 11, 2015
PILLCAM SB 2 CAPSULE
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code NEZ·July 15, 2015
BRAVO PH CAPSULE DELIVERY DEVICE
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 11, 2015
BRAVO PH CAPSULE DELIVERY DEVICE
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·September 24, 2015
BRAVO PH CAPSULE DELIVERY DEVICE
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·July 28, 2015
BRAVO PH CAPSULE DELIVERY DEVICE
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 11, 2015
BRAVO PH CAPSULE DELIVERY DEVICE
FDA Adverse Event
Injury
·GIVEN IMAGING LTD.·Product code FFT·August 13, 2015