BEUDAMED
    22 results · 19ms · Sources: EU EUDAMED, US FDA

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    HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Signature

    FDA UDI
    SILEX MEDICAL, LLC·B33158620200·Babcock Grasping Forceps 10MM

    GC Ortho Chain

    FDA UDI
    Gc Orthodontics America Inc.·E53586202000011·GC ORTHO CHAIN Grey Medium

    GC Ortho Chain

    FDA UDI
    Gc Orthodontics America Inc.·D78886202000001·GC ORTHO CHAIN GREY MEDIUM 2M

    GC Ortho Chain

    FDA UDI
    Gc Orthodontics America Inc.·E53586202000001·GC ORTHO CHAIN GREY MEDIUM 2M

    LIFESOUND ESOPHAGEAL STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VITROS Chemistry Products Cl- Slides

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024173545·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024173552·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024139183·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024139176·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024173538·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024139169·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024173569·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024139152·

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2014

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 31, 2012

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 23, 2015

    Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·February 26, 2014

    Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DWF·January 30, 2014