8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DENTAL GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZAVATION TIGHTENER
FDA UDI
Zavation LLC·00197157014834·TIGER 2 FINAL TIGHTENER, T15
ANTIBODY TO HERPESVIRUS HOMINIS
FDA 510(k)
FDA Class 2
·Microbiology
ADKINS STRUT
FDA 510(k)
FDA Class 2
·Orthopedic
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·October 29, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·December 31, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014