7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
COAT-A-COUNT TOBRAMYCIN RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·February 5, 2014
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·August 5, 2009
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·August 30, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015