7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
ORTHO-KEV APPLIANCE REINFORCING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
IFA SENSIBAC NEOMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
LACRIMAL EFFICIENCY TEST (TM)
FDA 510(k)
FDA Unclassified
·Unknown
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 25, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code INM·January 3, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020