14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SPECTACLE FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
BEWELL, MODEL SC 20
FDA 510(k)
FDA Class 2
·Physical Medicine
T.A.G. Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
TIBIAL NAIL, STANDARD 10X390 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·March 17, 2010
CONVERTBL I.V.DUAL CHANNEL HSP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 20, 2011
CONVERTBL I.V..DUAL C
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·August 13, 2009
PRIMARY PLUMSET PP YSITE 272CM NDEHP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 19, 2012
CONVERTBL I.V. DUAL C
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009
CONVERTBL I.V. DUAL CHANNEL HSP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 7, 2011
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009
INCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code FPA·January 21, 2013
UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 31, 2010
NOVASURE
FDA Adverse Event
HOLOGIC, INC.·Product code MNB·May 6, 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