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Bio Trend®

MEDTRONIC, INC. · Model E95198-04 · UDI-DI 00613994750280

DTY
1
510(k) clearances
341
Adverse events
2
Recalls
5
Facilities

Description

EVAL INST E95198-04 BIOTREND UNIV DOM

Recalls

DateFirmReason
2010-11-01Terumo Cardiovascular Systems CorporationInaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.
2010-11-01Terumo Cardiovascular Systems CorporationInaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.

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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.