BEUDAMED
    11 results · 28ms · 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 ×

    ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5820804810·RONGEUR

    A&E Medical / Rotating Surgical Punches

    FDA UDI
    A & E MEDICAL CORPORATION·10841291105220·Rotating Surgical Punches, 1 per pouch

    SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULPDENT POST CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    2520274-2013-02151

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·April 26, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 11, 2014

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, B.V.·Product code MGB·July 21, 2008

    Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Alto Development Corp·March 7, 2018

    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