Given Imaging Ltd.
FDA Regulatory Profile
Given Imaging Ltd. appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 30 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2047-2025, Class I) was initiated on June 3, 2025. Its most recent 510(k) clearance was granted on March 8, 2018.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 30
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2047-2025 | Class I | Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esopha | June 3, 2025 |
| F-0418-2023 | Class II | Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps | February 2, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K180171 | PillCam Patency System | March 8, 2018 |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | September 1, 2017 |
| K170839 | RAPID Web | May 26, 2017 |
| K151086 | ManoScan System | April 28, 2016 |
| K153466 | PillCam COLON 2 Capsule Endoscopy System | January 14, 2016 |
| K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM | December 17, 2014 |
| DEN120023 | GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM | January 29, 2014 |
| K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | August 12, 2013 |
| K103025 | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES | May 13, 2011 |
| K101250 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES | March 7, 2011 |
| K103088 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT | January 14, 2011 |
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | December 1, 2010 |
| K101200 | PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE | September 30, 2010 |
| K090557 | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM | September 28, 2009 |
| K091405 | PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT | July 29, 2009 |
| K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | June 11, 2007 |
| K070475 | MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM | May 7, 2007 |
| K062786 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | October 18, 2006 |
| K060805 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | May 24, 2006 |
| K053639 | GIVEN DIAGNOSTIC SYSTEM | May 8, 2006 |