FDA applicant

Greatbatch Scientific

Clarence, NY1 decision1998–19980 recalls

FDA records 1 decision for Greatbatch Scientific (Clarence, NY) in 1998: 1 510(k) clearance. All are in product code FET (Endoscopic Video Imaging System/Component…). 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 Greatbatch Scientific’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Greatbatch Scientific since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Greatbatch Scientific by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Greatbatch Scientific

Which product codes does it file in?

What has FDA decided for it lately?