510(k) Report

FDA applicant

Polymed Laboratories

Tustin, CA2 decisions1985–19860 recalls

FDA records 2 decisions for Polymed Laboratories (Tustin, CA) from 1985 to 1986: 2 510(k) clearances. Most are in product codes DXE (Catheter, Embolectomy) and KOD (Catheter, Urological). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Polymed Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Polymed”

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