8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Digital Blood Pressure Monitor-Automatic Upper Arm Style
FDA 510(k)
FDA Class 2
·Cardiovascular
MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2013
MODIFICATION TO STAXX FX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARTISTE SOLUTION WITH SYS_VB50 UPDATE
FDA 510(k)
FDA Class 2
·Radiology
SYNGO SUITE FOR ONCOLOGY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 11, 2013
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD / HUNTINGTON·Product code MFK·June 8, 2011
UNK
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·September 17, 2008