74 results · 24ms · Sources: EU EUDAMED, 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