FDA applicant
Vanguard Medical Concepts, Inc.
FDA records 33 decisions for Vanguard Medical Concepts, Inc. (Lakeland, FL) from 1991 to 2005: 33 510(k) clearances. Most are in product codes NLH (Catheter, Recording, Electrode, Reprocessed) and KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 54 predicates, 6 of them its own earlier devices. 19 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vanguard Medical Concepts, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Vanguard Medical Concepts, Inc. since 2007.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Vanguard Medical Concepts, 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 “Vanguard”
FDA records each applicant name separately; these may or may not be the same firm.