24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PUNCTURE CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX HELIX - A
FDA 510(k)
FDA Class 2
·Radiology
REUSABLE INCONTIENT UNDERPAD
FDA 510(k)
FDA Class 1
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 30, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 4, 2014
WEBSTER CS EZ STEER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER·Product code DRF·December 13, 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