BEUDAMED
    17 results · 31ms · Sources: EU EUDAMED, US FDA

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    EPY-50

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

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160401·ChannelsOne 25mm Large

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717106859·Paper Points, Taper .04, Size #35, 100pcs/box

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062253·Mini Uni-Twin(TM) Bracket APC(TM) II Sondhi UL2...

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221093271·Mini Uni-Twin(TM) Bracket APC(TM) PLUS Sondhi U...

    ASTRA TECH IMPLANTS - DENTAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERCUFLEX URINARY DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LJE·August 31, 2023

    ORCA

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ODC·September 14, 2023

    ORCA

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ODC·September 14, 2023

    SYNFLATE VERTEBRAL BALLOON LRG

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 26, 2013

    C-TAPER TRIAL HEAD 36MM +5

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·February 16, 2011

    DTC MARGRON HIP REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·PORTLAND ORTHOPAEDICS LTD.·Product code KWY·March 28, 2008

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 8, 2015

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018