Given Imaging , Ltd.
Given Imaging , Ltd. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2018, with 2 FDA device recalls on record.
Top product codes for Given Imaging , Ltd.
FDA recalls by Given Imaging , Ltd.
- Z-3090-2026 — Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.
- Z-2047-2025 — 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)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Given Imaging , Ltd.
- K180171 — PillCam Patency System
- K170210 — PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
- K170839 — RAPID Web
- K151086 — ManoScan System
- K153466 — PillCam COLON 2 Capsule Endoscopy System
- K140284 — GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
- DEN120023 — GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
- K123864 — GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
- K103025 — GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
- K101250 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
- K103088 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
- K102543 — BRAVO PH MONITORING SYSTEM AND ACCESSORIES
- K101200 — PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
- K090557 — GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
- K091405 — PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
- K071153 — GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
- K070475 — MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
- K062786 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K060805 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K053639 — GIVEN DIAGNOSTIC SYSTEM
- K052184 — GIVEN DIAGNOSTIC SYSTEM
- K042960 — GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
- K041149 — GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
- K040248 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K032405 — GIVEN DIAGNOSTIC SYSTEM
- K031033 — GIVEN DIAGNOSTIC SYSTEM
- K022980 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K022362 — GIVEN DIAGNOSTICS SYSTEM
- K020341 — GIVEN DIAGNOSTIC SYSTEM
- DEN010002 — GIVEN DIAGNOSTIC IMAGING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.