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

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    Erisma-LP Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304221994·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111051951·SKLHN MAYO SCISS STR SMO 6 3/4

    MULTIPLE BIOPSY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ESTECH COBRA ELECTROSURGICAL UNIT & CABLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 8, 2013

    QUATTRODE 90-CM LENGTH PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD.·Product code MFK·September 5, 2008

    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

    V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 16, 2019

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023