72 results · 23ms · Sources: EU EUDAMED, US FDA

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SculpSure

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

3D SCANNER, MODEL 1230

FDA 510(k)
FDA Class 2 ·Radiology

HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)

FDA 510(k)
FDA Class 2 ·Radiology

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

PLM A+ SPANISH 110V

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 DEFIBIRILLATOR

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

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025