FDA applicant
Dart Medical Equipment
FDA records 7 decisions for Dart Medical Equipment (Mchenry, IL) from 1980 to 1982: 7 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). 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 Dart Medical Equipment’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dart Medical Equipment since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dart Medical Equipment’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