74 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMPOWR Porous Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar
FDA UDI
SKLAR CORPORATION·10649111457647·RUGBY DEL HEMO FCP 1X2 CVD 11 IN
WEBSTER DUO-DECAPOLAR CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO SCORPIO NRG KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·May 28, 2026
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 9, 2022
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 4, 2022
GEMSTAR 7 THERAPY
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 10, 2013
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC·Product code JJE·July 15, 2011
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXO·May 9, 2025
TRUWAVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·August 21, 2024
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 15, 2021
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 29, 2021
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 17, 2020
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 11, 2022