Given Imaging Ltd.

FDA Regulatory Profile

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
30
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2047-2025Class IBravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophaJune 3, 2025
F-0418-2023Class IIGiven Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crispsFebruary 2, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K180171PillCam Patency SystemMarch 8, 2018
K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0September 1, 2017
K170839RAPID WebMay 26, 2017
K151086ManoScan SystemApril 28, 2016
K153466PillCam COLON 2 Capsule Endoscopy SystemJanuary 14, 2016
K140284GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEMDecember 17, 2014
DEN120023GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEMJanuary 29, 2014
K123864GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEMAugust 12, 2013
K103025GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULESMay 13, 2011
K101250GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESMarch 7, 2011
K103088GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELTJanuary 14, 2011
K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIESDecember 1, 2010
K101200PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICESeptember 30, 2010
K090557GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEMSeptember 28, 2009
K091405PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELTJuly 29, 2009
K071153GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULEJune 11, 2007
K070475MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEMMay 7, 2007
K062786MODIFICATION TO GIVEN DIAGNOSTIC SYSTEMOctober 18, 2006
K060805MODIFICATION TO GIVEN DIAGNOSTIC SYSTEMMay 24, 2006
K053639GIVEN DIAGNOSTIC SYSTEMMay 8, 2006