FDA applicant
Medical Device Technologies, Inc.
FDA records 46 decisions for Medical Device Technologies, Inc. (Gainsville, FL) from 1992 to 2010: 46 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 60 predicates, 13 of them its own earlier devices. 19 recalls are linked to its devices, 3 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medical Device Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
3in 2026
Class I Class II/III not classified
Planning a device like Medical Device Technologies, 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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