48 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403030049·6mm Dilator
NA
FDA UDI
STRYKER CORPORATION·04546540756619·UNIVERSAL WEDGE 10MM X 20MM (1.5MM BORE)
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023087·B-P HIP FEMORAL RESURFACING CUP W/BIOCOAT & W/U...
SYNOVO HIP COMPONENTS
FDA UDI
Synovo Production·00814193025654·HIP FEMORAL RESURFACING CUP - 49MM
PULSECO HEMODYNAMIC MONITOR CM71
FDA 510(k)
FDA Class 2
·Cardiovascular
SUNI MAX
FDA 510(k)
FDA Class 1
·Dental
Biocore9 Femoral Resurfacing Component
FDA UDI
Biocore9, LLC·00810068850444·Biocore9 Femoral Resurfacing Head Component 49 mm
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·October 12, 2010
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL
GDC DETACHABLE COIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code HCG·November 23, 2009
GDC DETACHABLE COIL
FDA Adverse Event
Malfunction
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code HCG·October 20, 2009
GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·May 18, 2010
GDC DETACHABLE COIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code HCG·June 17, 2009
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·April 9, 2010
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur HBsAg
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HBSAG (HBS) AND HBSAG CONFIRMATORY
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HBSAG ASSAY