510(k) Report

FDA applicant

Harwill Medical (Pty), Ltd.

Crofton, MD4 decisions1998–19990 recalls

FDA records 4 decisions for Harwill Medical (Pty), Ltd. (Crofton, MD) from 1998 to 1999: 4 510(k) clearances. Most are in product codes BZH (Meter, Peak Flow, Spirometry) and HHT (Spatula, Cervical, Cytological). 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 Harwill Medical (Pty), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harwill Medical (Pty), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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