510(k) Report

FDA applicant

Edward Weck, Inc.

Mchenry, IL140 decisions1976–19925 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

2008: 22012: 12014: 12018: 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Edward Weck, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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) Report

Other applicant names beginning “Edward”

FDA records each applicant name separately; these may or may not be the same firm.