FDA applicant
Advance Medical Designs, Inc.
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
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
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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.
See the 510(k) ReportOther applicant names beginning “Advance”
FDA records each applicant name separately; these may or may not be the same firm.