BEUDAMED
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    Applied Biology, Inc.

    Manufacturer
    🇺🇸 United States·3 Basic UDI-DIs·3 Devices

    CS-001

    Device
    EU MDD · Eu Md Class 1 ·Applied Biology, Inc.·No longer on the market

    Daniel Alain N05

    Device
    EU MDD · Eu Md Class 1 ·Applied Biology, Inc.·No longer on the market

    Daniel Alain N01

    Device
    EU MDD · Eu Md Class 1 ·Applied Biology, Inc.·No longer on the market

    CS-001 Ant-Grey Hair

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Applied Biology, Inc.·1 device

    Danial Alain N01

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Applied Biology, Inc.·1 device

    Daniel Alain N05

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Applied Biology, Inc.·1 device

    Complex Science s.r.o.

    Authorized representative
    🇨🇿 Czechia·1 Manufacturer·3 Devices

    ORTHADAPT BIOIMPLANT

    FDA Adverse Event
    Injury ·PEGASUS BIOLOGICS, INC.·Product code FTM·November 2, 2009

    OLYMPUS LAB AUTOMATION SYSTEM

    FDA Adverse Event
    Other ·OLYMPUS DIAGNOSTICA LAB AUTOMATION GMBH·Product code JQP·December 10, 2007

    OPTIGUIDE FIBER OPTIC DIFFUSER

    FDA Adverse Event
    Malfunction ·PINNACLE BIOLOGICS, INC.·Product code MVG·February 28, 2020

    CARDIVA VASCADE 6/7F VCS

    FDA Adverse Event
    Injury ·CARDIVA MEDICAL, INC.·Product code MGB·May 9, 2018

    FOOTPRINT MEDICAL PICC 1.4FR

    FDA Adverse Event
    Injury ·FOOTPRINT MEDICAL, INC.·Product code LJS·July 8, 2016

    DURAGEN-UNKNOWN PRODUCT ID

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·August 24, 2018

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·February 3, 2023

    OPTIGUIDE FIBER OPTIC DIFFUSER

    FDA Adverse Event
    Malfunction ·PINNACLE BIOLOGICS, INC.·Product code MVG·December 19, 2019

    Synchron LX 20 PRO The SYNCHRON LX20 PRO is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent). Additionally, Synchron LX PRO Systems include Closed Tube Sampling (CTS) and Large Particle Immuno Assay (LPIA).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJE·October 22, 2010

    UniCel DxC 660i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI analyzers according to programming requirements. The UniCel DxC 600 or DxC 800 Synchron Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid (sample type is chemistry dependent). The UniCel DxI 600 or DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, and qualitative determination of various analyte concentrations found in human bodily fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEM·October 22, 2010

    UniCel DxC 880i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI analyzers according to programming requirements. The UniCel DxC 600 or DxC 800 Synchron Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid (sample type is chemistry dependent). The UniCel DxI 600 or DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, and qualitative determination of various analyte concentrations found in human bodily fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEM·October 22, 2010

    UniCel DxC 680i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI analyzers according to programming requirements. The UniCel DxC 600 or DxC 800 Synchron Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid (sample type is chemistry dependent). The UniCel DxI 600 or DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, and qualitative determination of various analyte concentrations found in human bodily fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEM·October 22, 2010