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

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

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 25, 2015

    Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDR·December 23, 2015

    Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·December 23, 2015

    Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·December 23, 2015

    Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·December 23, 2015

    Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·December 23, 2015