FDA applicant

Isolyer Co.

Norcross, GA1 decision1994–19940 recalls

FDA records 1 decision for Isolyer Co. (Norcross, GA) in 1994: 1 510(k) clearance. All are in product code NAB (Gauze / Sponge,Nonresorbable For External Use). 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, general and plastic surgery panel, where it files most

How often FDA has decided Isolyer Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Isolyer Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Isolyer Co.

Which product codes does it file in?

What has FDA decided for it lately?