BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    BD 2 PC 5 ML SYRINGE - DISCARDIT II 22G×1

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·February 4, 2022

    POWDERED VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257

    FDA 510(k)
    FDA Class 2 ·Immunology

    RESERVOIR 3ML MMT-332A

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 15, 2019

    INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 23, 2025

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·February 28, 2017

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·February 28, 2017

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 24, 2011

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 65MM

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code KTT·November 3, 2014

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 12, 2013

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    Injury ·APPLIED MEDICAL·Product code FZP·August 13, 2014

    PEDICLE SCREW 03.58.225 MUST MC SCREW Ø5X45 CANNULATED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2023

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025