34 results · 37ms · Sources: EU EUDAMED, US FDA

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X-Guide Surgical Navigation System

FDA 510(k)
FDA Class 2 ·Dental

S HEALTH

FDA 510(k)
FDA Class 2 ·Cardiovascular

E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)

FDA 510(k)
FDA Class 2 ·Physical Medicine

IMP,TSV,3.7,10,MTX,MG

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·April 28, 2021

IMP,TSV,3.7,10,MTX,MG

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·May 21, 2021

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DYG·February 26, 2026

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·April 12, 2026

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code DYG·August 13, 2025

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026

CENTURY BED

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·November 4, 2008

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 2, 2011

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·July 17, 2013

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code DYG·November 26, 2025

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code DYG·August 20, 2025

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·April 10, 2026

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·April 11, 2026

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code DYG·February 27, 2026

SWAN-GANZ VIP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·March 6, 2026