56 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RANDOX VALPROIC ACID
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040014660·Zirlux 16+ 0M3 55x19x15
Accunet
FDA UDI
ABBOTT VASCULAR INC.·08717648085161·RX ACCUNET Embolic Protection System 5.5/190 R...
Accunet
FDA UDI
ABBOTT VASCULAR INC.·08717648085154·RX ACCUNET Embolic Protection System 4.5/190 R...
Accunet
FDA UDI
ABBOTT VASCULAR INC.·08717648085178·RX ACCUNET Embolic Protection System 6.5/190 R...
Accunet
FDA UDI
ABBOTT VASCULAR INC.·08717648085185·RX ACCUNET Embolic Protection System 7.5/190 R...
EXHALE DOPPLER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234
FDA 510(k)
FDA Class 2
·General Hospital
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
FDA Recall
Terminated
·Abbott Vascular·Product code NTE·November 30, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·April 7, 2009
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 6, 2013
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·October 25, 2007
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-VS·Product code NIM·December 16, 2010
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NIM·April 6, 2007
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-VS·Product code NIM·December 23, 2010
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·August 7, 2007
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 19, 2013
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·February 14, 2011
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FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·February 12, 2008
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·February 7, 2011