510(k) Report

FDA applicant

Med-Tek Corp.

Indianapolis, IN16 decisions1978–19900 recalls

FDA records 16 decisions for Med-Tek Corp. (Indianapolis, IN) from 1978 to 1990: 16 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and DXN (System, Measurement, Blood-Pressure…). 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Med-Tek Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Med-Tek Corp.’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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