8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SAS BRUCELLAS ABORTUS ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123793·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 150mm
High Speed Handpieces and Accessories
FDA 510(k)
FDA Class 1
·Dental
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
FDA 510(k)
FDA Class 2
·Neurology
PRIME CARE (R) B900
FDA Adverse Event
Malfunction
·PRIMUS MEDICAL, LLC·Product code FNL·May 12, 2014
CAPSURE EPI
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DTB·February 9, 2013
2124215-2010-23383
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code NVY·January 7, 2011
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