FDA applicant

Renaissance Medical, Inc.

Dana Point, CA4 decisions1992–19940 recalls

FDA records 4 decisions for Renaissance Medical, Inc. (Dana Point, CA) from 1992 to 1994: 4 510(k) clearances. All are in product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

FDA decisions per year

No FDA decision for Renaissance Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Renaissance Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Renaissance”

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

Renaissance Pharmaceutical, Inc. 4 Renaissance Technology, Inc. 2 Renaissance Instruments, LLC 1

Renaissance Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Renaissance”