FDA applicant

Mani, Inc.

Washington, DC4 decisions2005–20066 recalls

FDA records 4 decisions for Mani, Inc. (Washington, DC) from 2005 to 2006: 4 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and GAR (Suture, Nonabsorbable, Synthetic, Polyamide). Its devices cite 4 predicates, 0 of them its own earlier devices. 6 recalls are 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 Mani, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mani, Inc. since 2007.

Recalls per year

6in 2011

2007high 6 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Mani, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?