BEUDAMED
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    OrthoGold 100

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

    CORTRAK* Enteral Access System

    FDA UDI
    Avanos Medical, Inc.·00350770456317·Printer Battery

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450156360·

    EXTENSION SET, MODELS 1911-512

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 18, 2014

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·September 8, 2021

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·November 10, 2009

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 20, 2008

    CURVED METZENBAUM (LONG JAWS)

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS,DIV OF STRYKER CORP·Product code LFL·June 20, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 30, 2011

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 18, 2017

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·June 6, 2011

    Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016