FDA applicant
Florida Medical Industries, Inc.
FDA records 2 decisions for Florida Medical Industries, Inc. (Tarpon Springs, FL) from 1996 to 1997: 2 510(k) clearances. Most are in product codes MPO (Infant Heel Warmer (Chemical Heat Pack)) and IMD (Pack, Hot Or Cold, Disposable). 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 Florida Medical Industries, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Florida Medical Industries, Inc. since 2007.
Recalls per year
2in 2021
Class I Class II/III not classified
Planning a device like Florida Medical Industries, 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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