29 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEMOGLOBIN REAGENT
FDA 510(k)
FDA Class 2
·Hematology
CODMAN® HOLTER®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780517924·CODMAN® HOLTER® Ventricular Catheter 6cm
CODMAN HOLTER
FDA UDI
Cerenovus, Inc.·10886704040637·CODMAN HOLTER Ventricular Catheter 6cm
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
FDA 510(k)
FDA Class 2
·Microbiology
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·July 7, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·February 18, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·February 18, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·February 18, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·September 3, 2014
AMS INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·September 9, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·September 9, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·May 30, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·September 9, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·July 10, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·June 17, 2016
AMS INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·June 22, 2016
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·November 3, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·June 13, 2014
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Death
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·November 3, 2014