BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INTROCAN SAFETY IV CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KSEA DION-GRACIA SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDICAL COMPRESSOR

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

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

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

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

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

    NBCA LIQUID EMBOLIC SYSTEM 2

    FDA Adverse Event
    Death ·CORDIS NEUROVASCULAR, INC.·Product code MFE·June 12, 2008

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·August 11, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·October 2, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

    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

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023