FDA applicant
Maxxim Medical
FDA records 28 decisions for Maxxim Medical (Clearwater, FL) from 1994 to 2002: 28 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LZA (Polymer Patient Examination Glove). Its devices cite 12 predicates, 2 of them its own earlier devices. 52 recalls are linked to its devices.
FDA’s records also spell it “Maxxim Medical, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Maxxim Medical’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Maxxim Medical since 2007.
Recalls per year
42in 2009
Class I Class II/III not classified
Planning a device like Maxxim Medical’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) Report