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

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    HEMOCHRON(R) HEPARIN RESPONSE TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    TRU Straight Abutment NP 1.5mm cuff - Titanium

    FDA UDI
    STERNGOLD DENTAL LLC·00841549110146·TRU Straight Abutment NP 1.5mm cuff - Titanium....

    SPEEDPASS DISPOSABLE

    FDA UDI
    Biomet Orthopedics, LLC·00880304405264·

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746099915·DB BKT MASTER 6.0MM FLAT LANG UR LAT 018 T+8 A+...

    OsteoVation

    FDA UDI
    SKELETAL KINETICS LLC·00813845020122·OsteoVation QWIK Inject Bone Void Filler

    RYDERS

    FDA UDI
    FGX INTERNATIONAL INC.·00772956428596·

    FLOTRAC SENSOR

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES. DR·Product code DRS·May 29, 2009

    REVIVATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·July 26, 2019

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·April 21, 2011

    BD ECLIPSE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·August 17, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 9, 2013

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 20, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014

    Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025

    Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code JJE·December 19, 2024

    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