BEUDAMED
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    SAVANNAH-T

    FDA UDI
    SPINAL ELEMENTS·00840916103699·Ø4.5 x 25mm, Savannah®-T, DualFix Cortical-Canc...

    Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 16, 2016

    CORTERA SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·XTANT MEDICAL HOLDINGS, INC.·Product code NKB·September 12, 2024

    SWAN GANZ CATHETER

    FDA Adverse Event
    Death ·EDWARDS CVS DIV. BAXTER HEALTHCARE CORP.·Product code DYG·March 2, 1996

    CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC STYLET

    FDA Adverse Event
    Death ·AVANOS MEDICAL INC.·Product code KNT·May 9, 2023

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·March 11, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·November 1, 2012

    Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

    FDA Recall
    Open, Classified ·XTANT Medical Holdings, Inc·Product code NKB·August 21, 2024

    Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

    FDA Enforcement
    Class II ·Ongoing·XTANT Medical Holdings, Inc·October 23, 2024

    PLASMABLADE TNA

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY, LLC·Product code GEI·September 4, 2015

    CORAIL AMT COLLAR STD DNI

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWA·December 5, 2012

    CORAIL AMT COLLAR STD DNI

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWA·December 5, 2012

    TESIO CATHETER

    FDA Adverse Event
    Death ·MEDCOMP·Product code LFJ·May 3, 2000

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·February 6, 2015

    HEARTWARE HVAD

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·July 8, 2014

    AVEIR¿ DELIVERY CATHETER

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code PNJ·August 27, 2025

    FOOTSWITCH PULSAR WIRELESS

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY, LLC·Product code GEI·April 20, 2015

    KENDALL ENTRIFLEX

    FDA Adverse Event
    Death ·CARDINAL HEALTH·Product code BSS·April 30, 2024

    PEAK PULSAR II GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY, LLC·Product code GEI·September 4, 2015

    THE ROSE BED

    FDA Adverse Event
    Other ·STRYKER MEDICAL QUEBEC LP·Product code FNL·November 30, 2010