7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P
FDA 510(k)
FDA Class 2
·Radiology
COMFORT EZ
FDA 510(k)
FDA Class 2
·General Hospital
GT5 conductive & abrasive gel
FDA 510(k)
FDA Class 2
·Neurology
DIGITALDIAGNOST
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS DMC GMBH·Product code MQB·August 9, 2011
TRILOGY O2
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·August 6, 2014
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018