BEUDAMED
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    BT-350

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FETAL MONITOR/CARDIOTOCOGRAM

    FDA Adverse Event
    Injury ·BISTOS CO., LTD.·Product code HGL·January 29, 2018

    Neodent

    FDA UDI
    JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878047155·NGS NARROW INITIAL DRILL

    Silex

    FDA UDI
    SILEX MEDICAL, LLC·B331EZL103545·Slide Locking Long Cup Tooth Dissecting Forceps

    SELF CENTERING

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295003359·SELF CENTERING BI-POLAR HEAD 28mm ID 45mm OD

    SurgyCut

    FDA UDI
    U.S. SURGITECH INC.·00810014632094·SurgyCut L - Hook with Suction & Electrode, 5mm...

    NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221

    FDA 510(k)
    FDA Class 2 ·Hematology

    MASUNAGA since 1905

    FDA UDI
    MASUNAGA OPTICAL MFG.CO.,LTD.·04580786589440·

    XEN 45 GTS

    FDA Adverse Event
    Injury ·ALLERGAN (IRVINE)·Product code KYF·June 11, 2025

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 26, 2011

    SELF CENT HIP 45X28 GRY

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWY·April 4, 2019

    GALAXY G3 MINI 1.5MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 24, 2020

    ON-Q PAINBUSTER

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEA·March 16, 2007

    GALAXY G3 MINI 2.5MM X 4.5CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 29, 2020

    MICRUSFRAME10 6MM X 26CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·July 14, 2020

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·January 30, 2026

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021