BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    Heat Pain Pro

    FDA 510(k)
    FDA Class 2 ·Neurology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821601150·

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486019983·MCK PF TEMPLATE (5 RIGHT)

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694004350·LOGIC Distractor, Right 24mm

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306803888·Allis Forceps, 4x5 Teeth, 15cm

    LINK Instruments - Impactors, extractors and insertion

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575390489·Surgical mallet - General Instrument

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023865·B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 25 MM

    Endo-Model Knee System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575390472·Surgical mallet - General Instrument

    ORTHOSIZE

    FDA 510(k)
    FDA Class 2 ·Radiology

    XVI R4.5

    FDA 510(k)
    FDA Class 2 ·Radiology

    Coaxial needle

    FDA UDI
    Möller Medical GmbH·04260277171759·

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE W/ PRE-ATTACH HOLDER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·May 16, 2023

    Widex

    FDA UDI
    Widex A/S·05706069923742·WIDEX MOMENT MBB3D 50 (Chestnut brown)

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

    BD NANO¿ ULTRA-FINE¿ PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·June 27, 2022

    BD NANO¿ ULTRA-FINE¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·December 3, 2021

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·February 10, 2016

    LMA MADomizer, 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