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Carnation Ambulatory Monitor

BARDY DIAGNOSTICS, INC. · Model B1000R2000 · UDI-DI 30851398007017

DSH Prescription
1
510(k) clearances
962
Adverse events (6 deaths)
0
Recalls
57
Facilities

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.