1,113 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008997·Zirlux 16+ B1 89x17x22
n/a
FDA UDI
Ortho Development Corporation·00822409072316·DAA Box Osteotome
Heat Stress Component
FDA UDI
Certified Safety Manufacturing, Inc.·00766588121192·Heat Stress Component
BRACHYSEED PD-103 MODELS #PD1
FDA 510(k)
FDA Class 2
·Radiology
ASCENT KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·January 5, 2017
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 20, 2013
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·March 4, 2011
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 15, 2014
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 20, 2016
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·March 10, 2016
GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 9, 2017
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·June 3, 2016
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·January 5, 2017
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 8, 2016
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 21, 2016
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 15, 2016
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 25, 2016