FDA applicant
Merete Medical GmbH
FDA records 25 decisions for Merete Medical GmbH (Berlin, DE) from 2005 to 2016: 25 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 70 predicates, 24 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Merete Medical, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Merete Medical GmbH’s devices, and how often a recall has named them.
FDA decisions per year
2in 2016
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Merete Medical 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 “Merete”
FDA records each applicant name separately; these may or may not be the same firm.