BEUDAMED
    17 results · 31ms · Sources: EU EUDAMED, US FDA

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    SMART GLOVE STERILE NITRILE EXAM GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GC Initial™

    FDA UDI
    Gc America Inc.·D0470128531·Initial LiSi Press Ingot LT-D4 (3gx5)

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450385746·

    EYE SENTIAL

    FDA UDI
    FGX INTERNATIONAL INC.·00193033444559·

    SCITON IMAGE HAIR REMOVAL LASER

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

    GUIDER SOFTIP GUIDING CATHETER XF 5F

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IPC® STYLUS TRANSNASAL BUR

    FDA Adverse Event
    Death ·MEDTRONIC XOMED INC.·Product code ERL·February 4, 2015

    CENTERPIECE PLATE FIXATION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NQW·January 13, 2017

    CENTERPIECE? PLATE FIXATION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NQW·April 17, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·March 1, 2013

    TRAUMA STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·March 3, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·March 12, 2008

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 28, 2023

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·September 25, 2023

    Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014