FDA applicant
Biodan Medical Systems, Ltd.
FDA records 20 decisions for Biodan Medical Systems, Ltd. (Shirley, NY) from 1982 to 1993: 20 510(k) clearances. Most are in product codes IKK (System, Isokinetic Testing And Evaluation) and ISD (Exerciser, Measuring). 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 Biodan Medical Systems, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biodan Medical Systems, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biodan Medical Systems, Ltd.’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