10,000 results
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62ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Detecto
FDA UDI
CARDINAL SCALE MANUFACTURING COMPANY·00809161199109·icon Digital Clinical Scale, Welch Allyn LXI Co...
IMMUNOCCULT-LXI
FDA 510(k)
FDA Class 2
·Hematology
CT Overlay - GE LXi
FDA UDI
Aktina Corp.·B365114700·
Detecto
FDA UDI
CARDINAL SCALE MANUFACTURING COMPANY·00809161198201·apex Digital Clinical Scale, Welch Allyn LXI Co...
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Detecto
FDA UDI
CARDINAL SCALE MANUFACTURING COMPANY·00809161198706·apex Digital Clinical Scale, Welch Allyn LXI Co...
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CFR·September 23, 2012
SPOT VITAL SIGNS LXI
FDA Adverse Event
Malfunction
·WELCH ALLYN·Product code DXN·October 25, 2013
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code JJE·June 17, 2005
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·February 23, 2012
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 1, 2012
SYNCHRON LXI 725 CLINICAL SYSTEM
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code JJE·August 29, 2003
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·October 1, 2012
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·December 7, 2011
SYNCHRON LX®I 725 SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·April 30, 2014
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·January 2, 2013
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·April 29, 2012
TRANSFORMER,120VAC/60 HZ,8 VDC
FDA Adverse Event
Malfunction
·WELCH ALLYN INC.·Product code MWI·November 26, 2024