20 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
FDA 510(k)
FDA Class 2
·Cardiovascular
DRESSING/CVP DRESSING CHANGE/HYPERALIMENT TRAYS
FDA 510(k)
FDA Class 1
·General Hospital
OBTURATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
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
EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIV·Product code DQO·April 25, 2007
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
EXCELSIOR SL-10 MICROCATHETER
FDA Adverse Event
Malfunction
·NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP·Product code DQO·January 3, 2007
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
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 13, 2013
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CGA·February 16, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 8, 2014
EXCELSIOR SL-10 MICROCATHETER
FDA Adverse Event
Malfunction
·NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP·Product code DQO·September 14, 2006
EXCELSIOR 1018 MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP, NEUROVASCULAR·Product code FOZ·August 2, 2006
LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Recall
Terminated
·Zest Anchors LLC·Product code DZE·January 16, 2014
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Enforcement
Class II
·Terminated·Zest Anchors LLC·February 12, 2014