FDA applicant

Flocare Medical

Wayne, PA5 decisions1990–19910 recalls

FDA records 5 decisions for Flocare Medical (Wayne, PA) from 1990 to 1991: 5 510(k) clearances. Most are in product codes BYD (Condenser, Heat And Moisture (Artificial Nose)) and BZO (Set, Tubing And Support, Ventilator (W Harness)). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Flocare Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Flocare Medical

Which product codes does it file in?

What has FDA decided for it lately?