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

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    BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·July 31, 2013

    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·December 26, 2018

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·July 31, 2013

    MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012

    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

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Enforcement
    Class II ·Terminated·X-NAV Technologies, LLC·April 20, 2016

    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