BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR

    FDA UDI
    Intersurgical Incorporated·05030267153671·TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION S...

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982165350·3.5MM PROXIMAL TIBIA PLATE 6 HOLES/LEFT

    NeoFuse HA Enhanced PLIF/TLIF

    FDA UDI
    XENIX MEDICAL LLC·00818345020153·HA CAGE 24L x 10W x 7H

    Ophthlamic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·10841668115159·BARRAQUER SPECULUM Disposable with Finger tabs ...

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522410070·

    Symmetry Alm

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482046500·Symmetry® Retractor, Alm, Sharp, 4x4 Prongs, 3 in

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101223·ELLIS FOREIGN BODY SPUD

    MILLENIUM, MODELS 2000, 2001 AND 2002

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 7, 2018

    NEXIVA DIFFUSICS 22G X 1.00 IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 13, 2021

    UNKNOWN MENTOR SALINE IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 22, 2024

    UNKNOWN MENTOR SALINE IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 22, 2024

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·November 21, 2008

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·August 17, 2011

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013

    HEMOCHRON SIGNATURE ELITE

    FDA Adverse Event
    Malfunction ·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014