23 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
FDA 510(k)
FDA Class 2
·Hematology
PEI PLAQUE ELECTRODE ARRAY
FDA 510(k)
FDA Class 2
·Cardiovascular
XENON CIRCUIT
FDA 510(k)
FDA Class 2
·Radiology
SUPERA BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·November 29, 2010
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 4, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 4, 2014
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