13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Hometa
FDA UDI
Hometa, Inc.·00850024592018·Empty EVA Bag 250mL
Hometa
FDA UDI
Hometa, Inc.·00850024592063·Empty EVA Bags 4000mL
Hometa
FDA UDI
Hometa, Inc.·00850024592032·Empty EVA Bags 1000mL
Hometa
FDA UDI
Hometa, Inc.·00850024592001·Empty EVA Bag 150 mL
Hometa
FDA UDI
Hometa, Inc.·00850024592070·Drip Assist
Hometa
FDA UDI
Hometa, Inc.·00850024592056·Empty Eva Bags 3000mL
Hometa
FDA UDI
Hometa, Inc.·00850024592025·Empty EVA Bags 500mL
Hometa
FDA UDI
Hometa, Inc.·00850024592049·Empty EVA Bags 2000mL
ABC SELF-LOCKING CERVICAL SCREW 4.0X18MM
FDA Adverse Event
Malfunction
·AESCULAP IMPLANT SYSTEMS·Product code KWQ·March 21, 2017
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
FDA Enforcement
Class I
·Terminated·Abbott Diabetes Care, Inc.·December 25, 2013
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
FDA Enforcement
Class I
·Terminated·Abbott Diabetes Care, Inc.·December 25, 2013
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code NBW·November 18, 2013
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code NBW·November 18, 2013