8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ADDVANTAGE 38 ASPHERIC SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
THUNDERBEAT HANDPIECE (TB-0535FC)
FDA Adverse Event
Injury
·OLYMPUS·Product code GEI·June 26, 2015
ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
THUNDERBEAT 5MM X 35CM, FRONT ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code GEI·September 11, 2015
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·January 8, 2013
UNIVERSAL HIGH TORQUE DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·December 22, 2010
SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·July 17, 2014