BEUDAMED
    38 results · 14ms · Sources: EU EUDAMED, US FDA

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    Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code KLB·April 5, 2007

    Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190. (Note: Not distributed within the United States)

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code KLB·April 5, 2007

    VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 14, 2018

    VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 14, 2018

    VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 14, 2018

    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 14, 2018

    VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 14, 2018

    VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017

    VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017

    VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017

    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017

    VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017

    Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·August 6, 2004

    Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·August 6, 2004

    Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·April 29, 2020

    SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL The BARB assay provides a rapid screening procedure for determining the presence of barbiturates (BARB) and its metabolites in urine.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·May 6, 2020

    HoverMatt Patient Transfer Solution/Air Transfer Mattress

    FDA Recall
    Terminated ·D.T. Davis Enterprises Ltd.·Product code FRZ·September 13, 2005

    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code GDJ·July 2, 2013

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    FDA Enforcement
    Class II ·Terminated·B Braun Medical, Inc.·September 18, 2013

    Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010