510(k) Report

FDA applicant

Kerma Medical Products, Inc.

Chesapeake, VA5 decisions1991–19940 recalls

FDA records 5 decisions for Kerma Medical Products, Inc. (Chesapeake, VA) from 1991 to 1994: 5 510(k) clearances. Most are in product codes NAB (Gauze / Sponge,Nonresorbable For External Use) and LYU (Accessory, Surgical Apparel). 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 Kerma Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kerma Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kerma Medical Products, Inc.’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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