BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    SCHERER PORTABLE TOOTH POLISHER

    FDA 510(k)
    FDA Class 1 ·Dental

    Additive Orthopaedics Hammertoe Correction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    CLINITEK STATUS+

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KQO·November 9, 2012

    VISISTAT SKIN STAPLER 35W

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDT·September 22, 2010

    CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012