FDA applicant
Normed Medizin-Technik GmbH
FDA records 9 decisions for Normed Medizin-Technik GmbH (Tuttlingen, DE) from 1994 to 2016: 9 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 36 predicates, 2 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Normed Medizin-Technik GmbH’s devices, and how often a recall has named them.
FDA decisions per year
2in 2016
2026 so far, outlined.
Recalls per year
6in 2019
Class I Class II/III not classified
Planning a device like Normed Medizin-Technik 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) ReportOther applicant names beginning “Normed”
FDA records each applicant name separately; these may or may not be the same firm.