23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BISCO UNIVERSAL HYBRID COMPOSITE
FDA 510(k)
FDA Class 2
·Dental
FREE PROTEIN S REAGENT CAT. NO. 5363
FDA 510(k)
FDA Class 2
·Hematology
MATERIAL TOOTHSADE RESIN
FDA 510(k)
FDA Class 2
·Dental
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·June 27, 2014
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 30, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 24, 2010
BCD VANGUARD
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·March 4, 2022
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·November 20, 2020
CARDIOPLEGIA HEAT EXCHANGER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·April 29, 2020
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·April 12, 2019
BCD VANGUARD N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·January 15, 2024
CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED·Product code LNR·November 28, 2022
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·January 28, 2019
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·March 22, 2019
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·November 25, 2022
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 5, 2021
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·March 5, 2021
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·March 5, 2021
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·January 12, 2022
CARDIOPLEGIA HEAT EXCHANGER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·December 23, 2019