BEUDAMED
    219 results · 20ms · Sources: EU EUDAMED, US FDA

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    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·April 5, 2017

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FRN·January 26, 2017

    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

    FDA Recall
    Terminated ·Northgate Technologies, Inc.·Product code FFK·May 24, 2017

    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

    FDA Enforcement
    Class II ·Terminated·Northgate Technologies, Inc.·November 15, 2017

    VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101

    FDA Recall
    Terminated ·bioMerieux·Product code LJC·August 6, 2003

    CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, LTD.·October 31, 2018

    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, LTD.·October 31, 2018

    CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, LTD.·October 31, 2018

    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, LTD.·October 31, 2018

    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 28, 2018

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

    FDA Enforcement
    Class II ·Terminated·Cardiac Assist, Inc·February 19, 2020

    Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code MID·June 22, 2001

    Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code DHR·November 9, 2001

    Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LFX·February 24, 2000

    Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LJB·March 19, 2001

    Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Alsius CoolGard Temperature Regulation System

    FDA Recall
    Terminated ·Alsius Corporation·Product code NCX·November 9, 2005

    Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016