8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
RECTAL TUBE DEVICE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
TRAY, BLOOD SAMPLING (PULSATOR II)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POWDERED VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CENTURION VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 9, 2014
ELECSYS 2010
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 12, 2007
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025