821 results
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61ms
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Sources: EU EUDAMED, US FDA
Ortho Solutions Inc
FDA registration
Ortho Solutions Inc·9 products·🇺🇸 United States
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
FDA Recall
Terminated
·Ortho Solutions Inc 330 Franklin Tnpk·Product code HWC·July 14, 2015
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
FDA Enforcement
Class II
·Terminated·Ortho Solutions Inc·October 14, 2015
VITROS 250 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·December 5, 2023
VITROS XT 7600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·June 17, 2024
VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code KHO·December 21, 2023
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·March 5, 2025
ORTHO SUMMIT PROCESSOR
FDA Adverse Event
Other
·HAMILTON BONADUZ AG·Product code JJE·October 31, 2005
VITROS XT 7600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·December 6, 2022
VITROS XT 7600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·March 17, 2025
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·September 20, 2024
VITROS 350 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·April 10, 2023
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·December 21, 2023
VITROS 350 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·January 3, 2024
VITROS 350 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·August 31, 2022
VITROS 4600 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·January 4, 2023
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·November 19, 2015
VITROS XT 7600 INTEGRATED SYSTEM
FDA Adverse Event
Injury
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·August 29, 2025
VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code KHO·March 12, 2024
VITROS 350 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·February 5, 2026