BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    ADVANCED LUNG ANALYSIS II

    FDA 510(k)
    FDA Class 2 ·Radiology

    REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CODMAN VPV PROGRAMMER REVISED

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·September 22, 2021

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 21, 2018

    MENTOR CORPORATION WORLDWIDE

    FDA Adverse Event
    Malfunction ·MENTOR CORP, WORLDWIDE·Product code FTR·April 3, 2013

    FLEXTEND IS-1 BI POSITIVE FIX

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

    SECURA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·April 6, 2011

    NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HRS·June 11, 2018

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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