FDA applicant
Given Imaging, Ltd.
FDA records 30 decisions for Given Imaging, Ltd. (Yoqneam, IL) from 2001 to 2018: 28 510(k) clearances and 2 De Novo grants. Most are in product codes NEZ (System, Imaging, Gastrointestinal, Wireless…) and NSI (System, Imaging, Esophageal, Wireless, Capsule). Since 2016 its 510(k)s took a median of 220 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 106 predicates, 102 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Given Imaging, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Given Imaging, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Given”
FDA records each applicant name separately; these may or may not be the same firm.