FDA applicant
Edward Weck, Inc.
FDA records 140 decisions for Edward Weck, Inc. (Mchenry, IL) from 1976 to 1992: 140 510(k) clearances. Most are in product codes HNR (Forceps, Ophthalmic) and GEI (Electrosurgical, Cutting & Coagulation &…). 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Edward Weck, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Edward Weck, Inc. since 2007.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Edward Weck, Inc.’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 “Edward”
FDA records each applicant name separately; these may or may not be the same firm.