510(k) Report

FDA applicant

Biodex Corp.

Shirley, NY7 decisions1986–19920 recalls

FDA records 7 decisions for Biodex Corp. (Shirley, NY) from 1986 to 1992: 7 510(k) clearances. All are in product code IKK (System, Isokinetic Testing And Evaluation). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Biodex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biodex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biodex Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biodex 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) Report

Other applicant names beginning “Biodex”

FDA records each applicant name separately; these may or may not be the same firm.