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Transonic

TRANSONIC SYSTEMS INC. · Model HD03 · UDI-DI 08774660000435

MQS
1
510(k) clearances
271
Adverse events (12 deaths)
1
Recalls
2
Facilities

Recalls

DateFirmReason
2015-02-17Transonic Systems IncCustomer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displ

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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.