510(k) Report

FDA applicant

Dms Miami, Inc.

Vega Baja, GW3 decisions1991–19910 recalls

FDA records 3 decisions for Dms Miami, Inc. (Vega Baja, GW) in 1991: 3 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FYA (Gown, Surgical). 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 Dms Miami, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dms Miami, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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