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

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    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Mini-Taurus

    FDA UDI
    Rmo, Inc.·00885797100726·ALEX MT 022 HK/3 5-5 20EA

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434571·Tasso+ convenience kit allows self-collection o...

    Luxe™ 2.5 Semi-custom loupe

    FDA UDI
    METREX RESEARCH, LLC·00850036373476·Semi-custom loupe with Luxe™ 2.5 plano oculars,...

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161016510·Anterior Tray II

    AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIO-RAD %CDT TIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LCS M BRDG BRG STD+/LG 10.0

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code NJL·May 9, 2013

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 19, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

    HAHN TAPERED IMPLANT 4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 3, 2022

    HAHN TAPERED IMPLANT 4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 3, 2022

    11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·July 6, 2017

    AXIUM

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code HCG·November 10, 2023

    NV MICROCATHETER

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·November 10, 2023

    TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated 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 27, 2012

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

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