10,000 results · 62ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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