9 results
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17ms
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Sources: EU EUDAMED, US FDA
AXSYM ULTRASENSITIVE HTSH II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150669·K-WIRE - SINGLE TROCAR THREADED 2.4mm DIA x 200mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150591·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 200mm
Fortress Pedicular Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·February 9, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 4, 2011
ATTUNE CR FB INSRT SZ 7 5MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965·Product code JWH·July 23, 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