7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25
FDA 510(k)
FDA Class 2
·Hematology
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
FDA 510(k)
FDA Class 2
·Anesthesiology
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
FDA 510(k)
FDA Class 2
·Hematology
SHEATH, 2.9MM DIAGNOSTIC INNER
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code HIH·January 9, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 6, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 18, 2014
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020