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

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    VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code NGZ·April 20, 2017

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

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

    Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJF·May 21, 2007

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    FDA Recall
    Terminated ·Abaxis Inc·Product code JJG·December 11, 2019

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    FDA Enforcement
    Class II ·Terminated·Abaxis Inc·June 24, 2020

    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·February 20, 2009

    ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGZ·June 10, 2004

    Extension Line Slide Clamps; Product codes: SA-09847

    FDA Recall
    Terminated ·Arrow International Inc·Product code KGZ·April 11, 2018

    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

    Arrow Percutaneous Sheath Introducers

    FDA Recall
    Terminated ·Arrow International Inc·Product code KGZ·February 11, 2009

    Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

    FDA Recall
    Terminated ·Cook Inc.·Product code KGZ·April 15, 2016

    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

    FDA Recall
    Terminated ·Cook Inc.·Product code KGZ·February 1, 2017

    Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

    FDA Recall
    Terminated ·Cook Inc.·Product code KGZ·May 2, 2019

    Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

    FDA Recall
    Terminated ·Cook Inc.·Product code KGZ·April 15, 2016

    Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGZ·August 28, 2018

    VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    Tri-State Centurion Umbilical Vessel Tray without catheter, sterile, 5 per tray, Tri-State Supply Corporation, Howell, MI.; reorder UVT 170.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corporation·Product code KGZ·January 14, 2009

    OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.

    FDA Recall
    Terminated ·OPTI Medical Systems, Inc·Product code CGZ·April 20, 2009