7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ONCOPROBE II SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REALSEAL SE
FDA Adverse Event
Injury
·SYBRONENDO·Product code KIF·June 26, 2014
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
PARIETEX UGYTEX PP ANTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·November 21, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020