7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRISMA-FINE
FDA 510(k)
FDA Class 2
·Dental
NEWTOM VGI AND NEWTOM 5G
FDA 510(k)
FDA Class 2
·Radiology
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFEVEST WCD 4000 SYS
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 14, 2014
MX PRO COT LINE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·October 10, 2012
DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018