FDA applicant

Optivia Medical, LLC

Winston-Salem, NC1 decision2006–20060 recalls

FDA records 1 decision for Optivia Medical, LLC (Winston-Salem, NC) in 2006: 1 510(k) clearance. All are in product code HIH (Hysteroscope (And Accessories)). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Optivia Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optivia Medical, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Optivia Medical, LLC

Which product codes does it file in?

What has FDA decided for it lately?