BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134090·Trial, TLIF, 27L OB STR 7Deg, 9mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0830090·Persuader, Rod Reduction, Kerrison Type

    ELECSYS FSH CALSET II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AT HOME DRUG TEST, MODEL 9074

    FDA 510(k)
    FDA Unclassified ·Unknown

    OMNIGUIDE BEAMPATH FIBER AND ADAPTER

    FDA Adverse Event
    OMNIGUIDE, INC.·Product code GEX·October 19, 2010

    RETROFLEX 3 SAPIEN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code NPT·April 29, 2013

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 10, 2011

    9617604-2008-00091

    FDA Adverse Event
    Injury ·Product code CAH·July 18, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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