34 results
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26ms
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Sources: EU EUDAMED, US FDA
ACCUMETRA
FDA registration
ACCUMETRA·1 product·🇺🇸 United States
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
FDA 510(k)
FDA Class 2
·Hematology
PIPELINE FLEX EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·July 10, 2019
VERIFYNOW P2Y12 TEST DEVICE
FDA Adverse Event
Other
·ACCUMETRICS·Product code JOZ·June 20, 2012
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·July 13, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·August 4, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·July 7, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·May 3, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·June 2, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·June 22, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·May 3, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·May 3, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·May 3, 2000
PLAVIX TEST
FDA Adverse Event
ACCUMETRICS·Product code JOZ·November 2, 2010
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·October 26, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·October 12, 2000
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS·Product code JOZ·March 11, 2005
ULTEGRA RPFA-TRAP
FDA Adverse Event
Malfunction
·ACCUMETRICS INC.·Product code JOZ·October 10, 2000
Accumetrics part number 29001 VerifyNow Instrument, printe power supply
FDA Recall
Terminated
·Accumetrics Inc·Product code JOZ·September 13, 2005
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
FDA Recall
Terminated
·Accumetrics Inc·Product code JOZ·February 6, 2012