1,542 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 19, 2006
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NDW·December 16, 2009
AU5431-02 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code NDW·March 21, 2013
AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02 UG ANALYZER)
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code NDW·March 19, 2013
LITHIUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NDW·October 21, 2025
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code NDW·October 21, 2010
LITHIUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NDW·September 9, 2025
ASSAY, PORPHYRIN, SPECTROPHOTOMETRY, LITHIUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS GMBH·Product code NDW·September 9, 2024
COBAS LITHIUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NDW·February 28, 2023
LITHIUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NDW·May 13, 2011
LITHIUM TEST KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code NDW·November 1, 2011
LITHIUM TEST KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code NDW·May 1, 2011
COBAS LITHIUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NDW·March 19, 2024
LI LITHIUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NDW·January 25, 2019
ADVIA Chemistry Calibrator
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code NDW·June 5, 2020
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code NDW·September 19, 2022
MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
FDA Recall
Terminated
·Sentinel CH SpA Via Robert Koch·Product code NDW·June 28, 2019
Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320
FDA Recall
Terminated
·Sentinel CH SpA Via Robert Koch·Product code NDW·June 28, 2019
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code NDW·September 19, 2022
UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
FDA Recall
Terminated
·Beckman Coulter Inc·Product code NDW·May 15, 2006