BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAEDA NEW NEEDLE DISPOSABLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COLOSHIELD COLONOSCOPY DRAPE MODEL E2000

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

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MAKO SURGICAL·Product code HRY·March 20, 2013

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MED SYS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·March 9, 2011

    HIVAB HIV-1/HIV-2 (RDNA) EIA

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code LRM·April 16, 2008

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 8, 2022

    BD¿ SYRINGE S2

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 12, 2018

    BD¿ SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 5, 2018

    3002682307-2018-00185

    FDA Adverse Event
    Malfunction ·July 31, 2018

    Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·April 1, 2015

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013