BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    AGNES

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

    NGSgo® Pronto demo Workflow reagents

    FDA UDI
    GenBio·00613745003702·

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193113562·HA PEEK EVOS Straight, ,13mmx9mmx 22mm , FLAT ...

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113592·PERIBULBAR NEEDLE 25GA 16MM

    XLP - Toyota - Black - XLPouch

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030111·XLP - Toyota - Black - XLPouch

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·October 26, 2010

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·October 26, 2010

    STRYKER XCEL ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIVO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN PRODUCT - TARGET DEVICE

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·October 17, 2008

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    EQ REVERSE TORQUE DEFINING SCREW KIT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·November 7, 2024

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·November 7, 2024

    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code HSX·March 21, 2023

    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·May 10, 2023

    Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·September 20, 2017

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024