BEUDAMED
    21 results · 29ms · Sources: EU EUDAMED, US FDA

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    Bodycad Unicompartmental Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517638861·CoRoent Ant TLIF PEEK, 8x11x30mm 12°

    ZenFlex

    FDA UDI
    Kerr Corporation·00195062029639·Rotary Files

    Origin Hip Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215051686·

    Paxeon Origin

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570200528·Origin Stem, Standard Offset Size 13 Collared

    Origin

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215001605·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111813020·Standard Offset, Collared Stem, Size 13

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    FDA Adverse Event
    Malfunction ·AOI, INC.·Product code LFL·January 23, 2014

    RESCUE EXTERNAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ALEUTIAN IBF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018

    STRATUS Stem

    FDA UDI
    AMPLITUDE SAS·03701089521284·

    CABLE,ECG LEAD SET,5L,50",IEC

    FDA UDI
    Datascope Corp.·10607567112244·CABLE,ECG LEAD SET,5L,50",IEC

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 17, 2014

    GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 21, 2013

    O-F 4000 PLUS

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 8, 2011

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 14, 2018

    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Enforcement
    Class II ·Terminated·American Optisurgical Inc·June 19, 2013

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Tenex Health Inc·May 14, 2014