8 results
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19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOCALL CARDIAC EVENT RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
SPI SYSTEM DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
FDA 510(k)
FDA Class 2
·Ophthalmic
ROOT CANAL INSTRUMENT
FDA Adverse Event
Other
·MICRO-MEGA SA·Product code EKS·January 25, 2010
SS COMPRESSION HIP SCREW LAG SCREW
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code KTT·September 19, 2016
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 21, 2013
LIFEPAK 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·January 19, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 1, 2014