FDA applicant
Colmed, Ltd.
FDA records 7 decisions for Colmed, Ltd. (Mchenry, IL) from 1979 to 1981: 7 510(k) clearances. Most are in product codes ELE (Implant, Subperiosteal) and EBA (Light, Surgical Headlight). 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 Colmed, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Colmed, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Colmed, Ltd.’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