12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SINGLE STEP FREE-T4 125I RADIOIMMUNO-
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788231440·Large Forward Angle Curette
Galaxy System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VIVO 50
FDA 510(k)
FDA Class 2
·Anesthesiology
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·July 31, 2017
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 30, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 7, 2012
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 6, 2015
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·September 15, 2015
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·May 12, 2017
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·May 12, 2017
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012