17 results
·
54ms
·
Sources: EU EUDAMED, US FDA
RELAIT TECHNOLOGY, INC
FDA Adverse Event
Injury
·RELAIT TECHNOLOGY, INC·Product code GEX·October 27, 2008
FRAXEL RE:PAIR LASER SYSTEM
FDA Adverse Event
Injury
·RELIANT TECHNOLOGIES, INC.·Product code GEX·April 29, 2009
FRAXEL SR 1500 LASER SYSTEM
FDA Adverse Event
Injury
·RELIANT TECHNOLOGIES, INC.·Product code GEX·February 22, 2007
FRAXEL SR750 LASER SYSTEM
FDA Adverse Event
RELIANT TECHNOLOGIES, INC.·Product code GEX·March 26, 2007
FRAXEL SR ERASER SSYTEM
FDA Adverse Event
Injury
·RELIANT TECHNOLOGIES, INC.·Product code GEX·January 28, 2006
FRAXEL SR LASER SYSTEM
FDA Adverse Event
Injury
·RELIANT TECHNOLOGIES, INC.·Product code GEX·January 12, 2006
FRAXEL SR LASER SYSTEM
FDA Adverse Event
Injury
·RELIANT TECHNOLOGIES, INC.·Product code GEX·October 3, 2005
FRAXEL SR LASER SYSTEM
FDA Adverse Event
Injury
·RELIANT TECHNOLOGIES, INC.·Product code GEX·October 26, 2006
FRAXEL SR LASER SYSTEM
FDA Adverse Event
Injury
·RELIANT TECHNOLOGIES, INC.·Product code GEX·February 8, 2005
FRAXEL SR LASER SYSTEM
FDA Adverse Event
Injury
·RELIANT TECHNOLOGIES, INC.·Product code GEX·August 12, 2005
BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code GXY·November 8, 2011
ΤΖΙΒΕΛΕΚΑΣ ΚΩΝΣΤΑΝΤΙΝΟΣ ΜΟΝΟΠΡΟΣΩΠΗ ΕΤΑΙΡΙΑ ΠΕΡΙΟΡΙΣΜΕΝΗΣ ΕΥΘΥΝΗΣ
Importer
4 Manufacturers
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Ortho Organizers GmbH
Importer
🇩🇪 Germany·34 Manufacturers
PROCLINIC SAU
Importer
🇪🇸 Spain·33 Manufacturers
Internacional Ventur S.A.
Importer
🇪🇸 Spain·23 Manufacturers
Pharmacare Distribution Limited
Importer
🇮🇪 Ireland·23 Manufacturers