10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OSTEONICS UNIPOLAR ENDO HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
ZAVATION
FDA UDI
Zavation LLC·00842166117617·Polyaxial Screw 4.5mm x 34mm
DIGITAL SCREENING AUDIOMETER DSA6214
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ENEMA BULB
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 30, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 30, 2024
CAPSURE EPI
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code NVN·February 11, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 10, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 17, 2014
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020