510(k) Report

FDA applicant

Advance Medical Designs, Inc.

Marietta, GA32 decisions1985–20234 recalls

FDA records 32 decisions for Advance Medical Designs, Inc. (Marietta, GA) from 1985 to 2023: 32 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and DTL (Adaptor, Stopcock, Manifold, Fitting…). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 recalls are 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 hospital panel, where it files most

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

FDA decisions per year

1in 2023

2017: 12023: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Advance Medical Designs, 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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Other applicant names beginning “Advance”

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