BEUDAMED
    30 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.

    FDA Recall
    Terminated ·Medela Inc·Product code OHH·April 4, 2011

    Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHH·December 15, 2014

    Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHH·May 7, 2015

    Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHH·May 7, 2015

    Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·January 16, 2019

    Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests.

    FDA Recall
    Terminated ·Fisher Diagnostic, A Company of Fisher Scientific LLC·Product code GHH·July 1, 2004

    PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·June 5, 2009

    Pathfast D-Dimer, Reference number: PF1051-KUS

    FDA Recall
    Terminated ·Lsi Medience Corporation 13-4 Uchikanda·Product code GHH·August 16, 2016

    Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHH·April 13, 2016

    PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·April 2, 2009

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Recall
    Terminated ·BBI SOLUTIONS OEM LTD 8 Tom McDonald Avenue Dundee United Kingdom·Product code GHH·June 1, 2016

    Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·January 16, 2019

    Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code GHH·June 21, 2005

    Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.

    FDA Recall
    Terminated ·Alere San Diego·Product code CHH·November 16, 2010

    Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere Triage D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GHH·May 2, 2014

    Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHH·March 17, 2016

    PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·June 7, 2019

    Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHH·April 3, 2017

    The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.

    FDA Recall
    Terminated ·Horiba Instruments Inc·Product code CHH·January 11, 2016

    Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CHH·July 20, 2016