FDA applicant
Metek GmbH
FDA records 2 decisions for Metek GmbH (Leinefelde, DE) from 1978 to 2007: 2 510(k) clearances. Most are in product codes JFB (Table, Physical Therapy, Multi Function) and FLL (Continuous Measurement Thermometer). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Metek Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Metek GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Metek GmbH’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