BEUDAMED
    8 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·March 2, 2016

    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing

    FDA Enforcement
    Class II ·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·October 10, 2018

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Enforcement
    Class II ·Terminated·Paa Laboratories Inc·July 24, 2013

    Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Integra York PA, Inc·December 21, 2016

    Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Integra York PA, Inc·December 21, 2016

    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Integra York PA, Inc·June 8, 2016

    Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.

    FDA Enforcement
    Class II ·Terminated·Integra York PA, Inc·September 17, 2014