BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    REPROCESSED PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pathway

    FDA UDI
    SPINAL ELEMENTS·00840916112998·Pathway ACIF 7mm, 7 degrees

    HAGER OUTBACKS GREEN

    FDA UDI
    HAGER WORLDWIDE, INC.·D2481007071·Protective Eyewear

    Oticon

    FDA UDI
    Oticon A/S·05707131164070·ACTO, BTE 13 P STG

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471155899·T Nat D 018 Up

    NITANIUM® RCS STRAIGHT LEGS

    FDA UDI
    Ortho Organizers, Inc.·00190707066994·.020 Lower Nitanium® RCS Straight Legs Archwires

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521007070·

    Biliary Drainage Tube

    FDA UDI
    OLYMPUS MEDICAL SYSTEMS CORP.·04953170046292·

    Young Specialties

    FDA UDI
    Young Innovations, Inc.·00840326425435·NiTi Thermal Archwire, NAT .018 Upper Dimple 10EA

    ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEICA COLPOSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 24, 2022

    VASCUTRAK PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·January 7, 2011

    CARDIAC MONITOR

    FDA Adverse Event
    Malfunction ·HILL-ROM·Product code DRT·May 21, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    ENDURANT STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 18, 2011

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 22, 2012

    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·September 29, 2021

    INFANT BIAS FLOW BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 2, 2011

    Alinity m System, Part No. 08N53-002

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular, Inc.·January 12, 2022