FDA applicant

Promedica Products, Inc.

Newport Beach, CA6 decisions1988–19920 recalls

FDA records 6 decisions for Promedica Products, Inc. (Newport Beach, CA) from 1988 to 1992: 6 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and DWF (Catheter, Cannula And Tubing, Vascular…). 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, general and plastic surgery panel, where it files most

How often FDA has decided Promedica Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Promedica Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Promedica”

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

Promedica, Inc. 2 Promedica Sdn. Bhd. 1

Promedica Products, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Promedica”