BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    UNASSIGNED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    iTotal® PS Tibial Keel Punch Tip

    FDA UDI
    Conformis, Inc.·00850268007330·iTotal® PS 12mm Tibial Keel Punch Tip Reusable ...

    VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE

    FDA 510(k)
    FDA Class 2 ·Dental

    BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    H 105700#TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·May 5, 2015

    HQV 32902#INTEGRATED ADULT PACK

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·June 22, 2015

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 26, 2013

    LIGHTSPEED VCT

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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