FDA applicant
Controlled Therapeutics Corp.
FDA records 4 decisions for Controlled Therapeutics Corp. (Malvern, PA) in 1989: 4 510(k) clearances. Most are in product codes KOZ (Beads, Hydrophilic, For Wound Exudate Absorption) and KGX (Tape And Bandage, Adhesive). 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 Controlled Therapeutics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Controlled Therapeutics Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Controlled Therapeutics 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 “Controlled”
FDA records each applicant name separately; these may or may not be the same firm.