8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PAXgene® Blood DNA Tube
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Puget Sound Energy - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
FDA 510(k)
FDA Class 2
·Radiology
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022