BEUDAMED
    24 results · 27ms · Sources: EU EUDAMED, US FDA

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    SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIRECT TIBC CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    2.0/2.4 CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

    PRESSON

    FDA Adverse Event
    Injury ·NEXUS SPINE, LLC·Product code MNI·July 15, 2022

    BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·July 26, 2019

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·September 26, 2019

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·August 21, 2019

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·April 24, 2019

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·October 3, 2019

    MEDICAL COMPRESSOR

    FDA Adverse Event
    Malfunction ·EKOM SPOL. S.R.O.·Product code BTI·April 5, 2011

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·April 5, 2013

    FUSION, OMNI-TOME SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·WILSON COOK MEDICAL INC·Product code KNS·March 10, 2011

    SPEEDBAND SUPERVIEW SUPER 7 LIGATOR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·June 12, 2008

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·August 23, 2019

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·March 28, 2019

    ULTRASAFE X100L PR GREY SSL SDZ

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·September 11, 2019

    BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·October 30, 2013

    Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DIF·September 23, 2013