BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    NeuroStar TMS Therapy System

    FDA 510(k)
    FDA Class 2 ·Neurology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821607030·ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

    OTS PG&E Field Kit

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588107035·OTS PG&E Field Kit

    STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PMP4 BP PRO BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·June 10, 2013

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 30, 2011

    LECTROVAC 6-INCH

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 29, 2008

    GALAXY G3 MINI 2MM X 6CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2021

    LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014