30 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO OASYS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
GE VISION NUCLEAR MEDICINE WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
EXCELSIOR MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code DQY·April 13, 2010
EXCELSIOR SL-10 MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC, NEUROVASCULAR DIV.·Product code DQY·July 10, 2009
EXCELSIOR SL-10 PRE-SHAPED 45 CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION·Product code DQO·December 12, 2007
E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES
FDA Adverse Event
Injury
·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012
E.CAM, SYMBIA E
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012
EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIV·Product code DQO·April 25, 2007
E.CAM, SYMBIA E
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013
EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION·Product code DQO·November 14, 2007
EXCELSIOR SL-10 MICROCATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code DQO·May 1, 2007
EXCELSIOR SL-10 PRE-SHAPED CATHETER
FDA Adverse Event
Malfunction
·NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP·Product code DQO·September 14, 2006
E.CAM
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014
EXCELSIOR SL-10 MICROCATHETER
FDA Adverse Event
Malfunction
·NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP·Product code DQO·January 3, 2007
SYMBIA T-SERIES
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013
EXCELSIOR SL-10 MICROCATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV·Product code DQO·September 15, 2006
EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHER
FDA Adverse Event
Malfunction
·NEUROVASCULAR, DIVISION OF BOSTON SCIENTIFIC CORPORATION·Product code DQO·January 3, 2007
EXCELSIOR SL-10 PRE-SHAPED J MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code DQO·August 17, 2007
SYNREAM REAMER HEAD Ø9
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·April 23, 2013