41 results
·
20ms
·
Sources: EU EUDAMED, US FDA
GILTECH PLUS CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·December 9, 2015
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Kubtec Mozart (Xpert42)
FDA 510(k)
FDA Class 2
·Radiology
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·January 8, 2016
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·November 20, 2025
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 18, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 3, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 5, 2026
XPS HANDPIECE - VISAO
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 2, 2021
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 16, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 28, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 17, 2026
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Malfunction
·NIPRO CORPORATION *USD*·Product code KDI·February 28, 2013
RICHARD WOLF
FDA Adverse Event
Injury
·RICHARD WOLF MEDICAL INSTRUMENTS·Product code GEI·February 4, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 6, 2014
DRILL 3334800 VISAO 80K HANDPIECE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017