9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOLTER FOR WINDOWS
FDA 510(k)
FDA Class 2
·Cardiovascular
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471130463·K-WIRE - DOUBLE TROCAR WITH GUIDE 0.6mm DIA x 1...
THERMOSKIN CONDUCTIVE PADS
FDA 510(k)
FDA Class 2
·Neurology
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 28, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·December 16, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2014
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014