7 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONGER WIRING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAPD TRANSFER SET JC9044
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZAGA Zygomatic System
FDA 510(k)
FDA Class 2
·Dental
ELLIPSE ST DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 24, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·January 2, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 3, 2010
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