BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120305471·Diamond, cone rounded edge, medium grit

    NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ATR TECNIKA

    FDA 510(k)
    FDA Class 1 ·Dental

    CODMAN HAKIM VALVE PROGRAMMER & TRANSMITTER

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC.·Product code JXG·April 2, 2013

    AFFINITY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code HDD·March 22, 2011

    E360 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 15, 2008

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 2012

    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