FDA applicant
Healthmate, Inc.
FDA records 3 decisions for Healthmate, Inc. (Northbrook, IL) from 1984 to 1985: 3 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and FSE (Table, Operating-Room, Manual). 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Healthmate, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Healthmate, Inc. since 2007.
Recalls per year
1in 2011
Class I Class II/III not classified
Planning a device like Healthmate, 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 “Healthmate”
FDA records each applicant name separately; these may or may not be the same firm.