15 results
·
26ms
·
Sources: EU EUDAMED, US FDA
GENDEX 765DC, MODEL 110-0154
FDA 510(k)
FDA Class 2
·Dental
CAPSTONE PTC™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169187429·SPACER 3992610 26MM X 10MM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198819·AK3 Ultra Insert Trial Size 6, 10mm
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO BEACON STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 3, 2017
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015
LEAD 3876-45 OCTAD 1X8 SC
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·March 7, 2013
CAPSUREEPI
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·August 8, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020