BEUDAMED
    18 results · 43ms · Sources: EU EUDAMED, US FDA

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    3.0T TORSO PHASED ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ANCURE LLIAC BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014

    TRUE BALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014

    PEN NEEDLE 31X5

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FMF·January 7, 2019

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·January 22, 2015

    ENDOVIVE¿ JEJUNAL FEEDING TUBE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·April 2, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 9, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·April 16, 2008

    LIFEWISE BLOOD PRESSURE MONITOR

    FDA Adverse Event
    Injury ·RADIOSHACK·Product code DXN·October 20, 2004

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 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