FDA applicant
Proto-Med, Inc.
FDA records 4 decisions for Proto-Med, Inc. (Mchenry, IL) from 1981 to 1984: 4 510(k) clearances. Most are in product codes HHF (Remover, Intrauterine Device, Contraceptive…) and CAW (Generator, Oxygen, Portable). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Proto-Med, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Proto-Med, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Proto-Med, 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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