FDA applicant
Weck
FDA records 2 decisions for Weck (Durham, NC) from 2002 to 2003: 2 510(k) clearances. All are in product code FZP (Clip, Implantable). 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Weck’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Weck since 2007.
Recalls per year
1in 2019
2007high 5 (2008) · low 0 (2007)2026
Class I Class II/III not classified
Planning a device like Weck’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 “Weck”
FDA records each applicant name separately; these may or may not be the same firm.