7 results
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19ms
·
Sources: EU EUDAMED, US FDA
TECNOL SECURE-ALL TUBE HOLDER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
MYVACET 5-07, 7-00 AND 9-40
FDA 510(k)
FDA Class 2
·Radiology
MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ECHELON*FLEX60 LONG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 4, 2010
PROMOTE QUADRA
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·January 13, 2014
ADVANTAGE FIT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·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