BEUDAMED
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    MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902

    FDA 510(k)
    FDA Class 1 ·Radiology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327300024·Peek customized complex-pls-craniofacial

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932854·Percutaneous Transluminal Angioplasty Balloon C...

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869667890·MOSS VRS Ti Connector, lateral, closed rod Ø6.0...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955931758·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955930652·Percutaneous Transluminal Angioplasty Balloon C...

    MOSES Raydar™

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Prestige Ameritech Pediatric/Child’s Face mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3012307300-2020-03233

    FDA Adverse Event
    Injury ·Product code BTO·April 22, 2020

    Widex

    FDA UDI
    Widex A/S·05706069369090·Widex CLEAR440 C4-CIC (Clay brown ) Right, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069369076·Widex CLEAR440 C4-CIC (Light beige ) Right, RC ...

    Widex

    FDA UDI
    Widex A/S·05706069369083·Widex CLEAR440 C4-CIC (Dark brown ) Right, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069552317·Widex CLEAR440 C4-CIC (Dark brown ) Right, RC coil

    TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU)

    FDA Adverse Event
    Injury ·Product code JOH·April 22, 2020

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 21, 2020

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    VASOVIEW HEMOPRO 2 WITH VASOSHIELD

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·November 21, 2012

    DEBAKEY TANGENT OCCL CLMP 11

    FDA Adverse Event
    Malfunction ·J. JAMNER SURGICAL INSTRUMENTS·Product code DXC·September 21, 2010

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012