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

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    APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Harvard Bond TE Mono

    FDA UDI
    Harvard Dental International GmbH·EHAR70836071·Light cure total etch one component bonding

    ONYX-RAD TELEMEDICINE PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 10, 2014

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    LAND AMERICA HEALTH & FITNESS·Product code FSA·April 29, 2013

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC SWISS MANUFACTURING FACILITY·Product code LGW·July 29, 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