7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
QUIKCLOT HEMOSTATIC DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
AlignRT Plus
FDA 510(k)
FDA Class 2
·Radiology
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
EVITA XL
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL, INC.·Product code CBK·August 17, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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