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BioTrend®
MEDTRONIC, INC. · Model E95198-04 · UDI-DI 00763000216276
1
510(k) clearances
341
Adverse events
2
Recalls
5
Facilities
Description
INS E95198-004 BIOTREND UNIV 8LDOM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-11-01 | Terumo Cardiovascular Systems Corporation | Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate. |
| 2010-11-01 | Terumo Cardiovascular Systems Corporation | Inaccurate 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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Get your free API keyRead the docsData 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.