34 results · 26ms · Sources: EU EUDAMED, US FDA

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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