14 results
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30ms
·
Sources: EU EUDAMED, US FDA
VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
FDA 510(k)
FDA Class 2
·Neurology
BIOCHEM 6100 NON-INVASIVE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLE, ASPIRATION & INJECTION, DISPOSABLE
FDA 510(k)
FDA Class 2
·General Hospital
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 28, 2021
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 24, 2021
RECIPROC BLUE FILES, 6X, STERILE
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·December 5, 2025
RECIPROC BLUE, 4X, STERILE
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·December 23, 2025
BUTTONSWITCH PENCIL
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·November 15, 2010
PROMUS ELEMENT ¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 9, 2013
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·July 1, 2014
TO GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015