BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hawkin Ambler Dilator

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030788·Hawkin Ambler Dilator 10-13 mm

    SYNTHES RESORABLE MESHES AND SHEETS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX MODULAR HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·December 17, 2018

    ZILVER BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·March 5, 2020

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 26, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

    SOFTCLIX ® PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 2, 2013

    SWAN NECK TNCKHOFF SN T2 LFT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FJS·March 22, 2011

    ACCU-CHEK SPIRIT INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·April 17, 2008

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 2, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2020

    FGE CATHETER, BILIARY, DIAGNOSTIC

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 13, 2019

    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