BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    INNOVASIVE SUTURE BONE FASTENER WITH SUTURE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLATINUM FOIL, VARIOUS SIZES

    FDA 510(k)
    FDA Class 2 ·Dental

    BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SILK SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAP·December 16, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 14, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 15, 2014

    Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·August 1, 2007

    UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJE·September 3, 2012

    AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including the detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JQW·April 11, 2012