BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    CTL BODY / SPINE ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01408N0·Cervical Rasp, 15 x 12, 8mm, 0 Degree, No Taper

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033562758·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0140060·Locking Cap, Temporary, Screw to Screw Distractor

    REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CM DRIVE IMPLANT 4.3X16 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·September 4, 2018

    CM DRIVE IMPLANT 4.3X13 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·September 4, 2018

    GOOD SAM CINCINNATI OH 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·December 11, 2008

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    ACCU-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·March 14, 2008

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012