BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    ALCOHAWK PRECISION

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRESS-FIT HEAD RESURFACING DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEE H10

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011

    ACL TOP

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005

    ACL TOP

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

    ACL ADVANCE

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·October 8, 2020

    EASYTRAK 3

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 9, 2013

    SYNCHROMED EL

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·March 25, 2011

    FLEXTEND IS-1 BI POSITIVE FIX

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 12, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 25, 2020

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018