38 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
FDA 510(k)
FDA Class 2
·Hematology
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0430200·Sagittal Bender, Double Ended Left
GALIX PACESTAR
FDA 510(k)
FDA Class 2
·Cardiovascular
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
ARROW CVC SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQY·April 9, 2021
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
ARROW CVC SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·November 11, 2022
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
ARROW CVC KIT: 5-LUMEN 8.5FR X 16CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·March 21, 2022
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
ARROW CVC SET: 16 GA X 8" (20 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·September 21, 2022
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 13, 2013
ACCURUS 800CS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 25, 2011
VENTAK PRIZM 2 VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
ARROW CVC SET: 16 GA X 8" (20 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·May 10, 2022
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014