342 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIQUID URINE CONTROL - LEVEL 3 (LIQ URN CONTROL 3)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273207576·The Randox Liquid Urine Control - Level 3 is in...
LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273215175·
LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273207118·
Liquid Glycated Haemoglobin (HbA1c) Control set (LIQ HbA1c CONTROL)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273214758·This product is intended for in vitro diagnosti...
LIQUID BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273215182·
LIQUID CHEMISTRY PREMIUM - LEVEL 3 (LIQ CHEM PREMIUM 3)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273207125·
LIQUID URINE CONTROL - LEVEL 2 (LIQ URN CONTROL 2)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273207569·The Randox Liquid Urine Control Level 2 is inte...
ENDURANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·August 12, 2020
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·August 12, 2020
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·August 12, 2020
VALIANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·August 12, 2020
CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LZH·May 5, 2020
CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code LZH·May 4, 2020
LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273216837·Intended for in vitro diagnostic (IVD) use as a...
LIQUID FROZEN LIPID CONTROL - LEVEL 1 (LIQ LPD CONTROL 1)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273215199·
LIQUID FROZEN LIPID CONTROL - LEVEL 3 (LIQ LPD CONTROL 3)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273215212·
LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273216820·Intended for in vitro diagnostic (IVD) use as a...
LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2)
FDA UDI
RANDOX LABORATORIES LIMITED·05055273215205·
CAIRE LOW LOSS 41L
FDA Adverse Event
Injury
·CAIRE, INC.·Product code BYJ·April 29, 2011
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·January 2, 2019