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

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PRIMER-P ADHESIVE AGENT

FDA 510(k)
FDA Class 2 ·Dental

IFA SENSIBAC ERYTHROMYCIN

FDA 510(k)
FDA Class 2 ·Microbiology

TRU-TOUCH VINYL, NON-STERILE

FDA 510(k)
FDA Class 1 ·General Hospital

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

HEARTWARE® VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Malfunction ·HEARTWARE, INC·Product code DSQ·June 26, 2014

TENDRIL SDX

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010

PACS SERVER

FDA Adverse Event
Malfunction ·GE HEALTHCARE INTEGRATED IT SOLUTIONS·Product code LLZ·December 28, 2012

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·August 8, 2024

TRUWAVE, VAMP PLUS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

TRUWAVE, VAMP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

TRUWAVE, VAMP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 26, 2024

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025

PEDIATRIC SOFTVENT

FDA Adverse Event
Injury ·UNOMEDICAL SDN BHD·Product code BTR·February 12, 2018

TRUWAVE, VAMP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·November 26, 2025