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MEDTRONIC, INC. · Model 304-03POR · UDI-DI 20613994697183

JOX
1
510(k) clearances
198
Adverse events (1 deaths)
2
Recalls
3
Facilities

Description

CRTG 304-03POR PORCINE HMS TAN 5L 9PK

Recalls

DateFirmReason
2009-12-14Medtronic IncRecently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP ref
2002-12-20Diagnostica Stago, Inc.Incorrect assay ranges on the assay value insert for Heparin Control 5.

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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.