BEUDAMED
    11 results · 31ms · Sources: EU EUDAMED, US FDA

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    DATACOM DC PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIPLE LUMEN CENTRAL VENOUS CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ORTHOGENESIS LPS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIG MOD TIB TRAY CEM COCR 4

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·May 30, 2018

    HOSPITAL NON-VENTED FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CBK·April 5, 2017

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 18, 2014

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2013

    3M RED DOT NEONATAL MONITORING ELECTRODES

    FDA Adverse Event
    Malfunction ·3M HEALTH CARE·Product code DRX·April 13, 2011

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 24, 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