BEUDAMED
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    BD PhaSeal Optima Closed System Drug Transfer Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021

    REX, VERSION 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    s-Clean SQ-SL Implant System Mini

    FDA 510(k)
    FDA Class 2 ·Dental

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·October 27, 2014

    PCA

    FDA Adverse Event
    Malfunction ·Product code FRN·April 26, 2013

    TERUMO ADVANCED PERFUSION SYSTEM I

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 29, 2011

    INFANT REUSABLE HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·November 7, 2013

    BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 20, 2022

    BD ECLIPSE¿ INJECTION NEEDLE WITH LUER-LOCK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 1, 2022

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021