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

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    SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code LOX·August 2, 2010

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code LOX·August 2, 2010

    MINITUB MULTI-PURPOSE CASSETTES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WATCHPAT100

    FDA Adverse Event
    Injury ·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code LOX·August 2, 2010

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code LOX·August 2, 2010

    CD HORIZON LEGACY MINI SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS, INC.·Product code MNI·February 3, 2012

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 4, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·May 8, 2008

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016