BEUDAMED
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    FLEXLIFE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123199·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 150mm

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127021725·Quick Connect Ratchet Screwdriver Handle

    SOMATOM Definition Edge, SOMATOM Definition AS/AS+

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATB ADVANCE PTA DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·January 4, 2011

    BD INTIMA-II IV CATHETER

    FDA Adverse Event
    Injury ·BD·Product code FOZ·July 17, 2014

    enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073). COMMON NAME: enGen Track System. The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 17, 2015

    enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073). COMMON NAME: enGen Track System. The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 6, 2015