FDA applicant

Given Imaging Ltd. (Medtronic)

Yoqneam Northern, IL2 decisions2021–20230 recalls

FDA records 2 decisions for Given Imaging Ltd. (Medtronic) (Yoqneam Northern, IL) from 2021 to 2023: 2 510(k) clearances. All are in product code NEZ (System, Imaging, Gastrointestinal, Wireless…). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Given Imaging Ltd. (Medtronic)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Given Imaging Ltd. (Medtronic) by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Given Imaging Ltd. (Medtronic)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Given”

FDA records each applicant name separately; these may or may not be the same firm.

Given Imaging, Ltd. 30 Given Imaging Ltd. (D.B.A. Medtronic) 1

Given Imaging Ltd. (Medtronic)

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Given”