7 results
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27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZORBA(TM) IGG REMOVAL REAGENT
FDA 510(k)
FDA Class 2
·Immunology
CHILDRENS SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
LIFEDOP DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·December 9, 2010
TENDRIL SDX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020