FDA applicant
Medtek Development Corp.
FDA records 2 decisions for Medtek Development Corp. (Bloomington, IL) in 1993: 2 510(k) clearances. All are in product code FYC (Gown, Isolation, Surgical). 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 Medtek Development Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Medtek Development Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medtek Development Corp.’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 “Medtek”
FDA records each applicant name separately; these may or may not be the same firm.