FDA applicant
Compumed, Inc.
FDA records 6 decisions for Compumed, Inc. (Mchenry, IL) from 1977 to 1999: 6 510(k) clearances. Most are in product codes KGI (Densitometer, Bone) and DSI (Detector And Alarm, Arrhythmia). 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 Compumed, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Compumed, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Compumed, 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