FDA applicant

Ormed Mfg., Inc.

Buffalo, NY23 decisions1983–19940 recalls

FDA records 23 decisions for Ormed Mfg., Inc. (Buffalo, NY) from 1983 to 1994: 23 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and GDY (Gauze/Sponge, Internal, X-Ray Detectable). 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 Ormed Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ormed Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ormed”

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

Ormed GmbH 2 Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE 1

Ormed Mfg., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ormed”