FDA applicant
Cooper Medical Devices Corp.
FDA records 7 decisions for Cooper Medical Devices Corp. (Mchenry, IL) from 1979 to 1981: 7 510(k) clearances. Most are in product codes HJI (Lens, Fundus, Hruby, Diagnostic) and HMX (Cannula, Ophthalmic). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cooper Medical Devices Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cooper Medical Devices Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cooper Medical Devices Corp.’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 “Cooper”
FDA records each applicant name separately; these may or may not be the same firm.