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

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    Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.

    FDA Enforcement
    Class III ·Terminated·Acumedia Manufacturers, Inc.·June 7, 2017

    Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories·June 7, 2017

    100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.

    FDA Enforcement
    Class III ·Terminated·Steris Corporation·September 12, 2012

    CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.

    FDA Enforcement
    Class III ·Terminated·Biochemical Diagnostics Inc·December 2, 2015

    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.

    FDA Enforcement
    Class III ·Terminated·Edwards Lifesciences, LLC·January 1, 2014

    PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)

    FDA Enforcement
    Class III ·Terminated·Tripath Imaging, Inc.·June 27, 2012

    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

    FDA Enforcement
    Class III ·Terminated·Degania Silicone, Ltd.·March 14, 2018

    ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019

    ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019

    ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·May 22, 2019

    ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·July 31, 2019

    IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

    FDA Enforcement
    Class III ·Ongoing·Volcano Corp·April 20, 2022

    RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device

    FDA Enforcement
    Class III ·Terminated·Teleflex Medical·July 24, 2019

    The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.

    FDA Enforcement
    Class III ·Terminated·Abbott Molecular·April 30, 2014

    RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device

    FDA Enforcement
    Class III ·Terminated·Teleflex Medical·July 24, 2019

    3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

    FDA Enforcement
    Class III ·Terminated·3M Company - Health Care Business·December 4, 2013

    Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

    FDA Enforcement
    Class III ·Terminated·Medtronic Vascular·October 3, 2018