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

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    Tumark Vision

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

    BI-METRIC XR-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304650688·

    Mouse anti-MSH6 (2D4B5) Concentrate

    FDA UDI
    LIFE TECHNOLOGIES CORPORATION·10190302008051·

    BI-METRIC XR-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304650336·

    SONTEC SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896000056·SONTEC SUCTION TUBE WITH FINGER CONTROL

    SONTEC SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0991804430·SONTEC SUCTION TUBE WITH FINGER CONTROL

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BD INSYTE AUTOGUARD BC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 20, 2013

    ASPIRATOR III

    FDA Adverse Event
    Malfunction ·WELLS JOHNSON COMPANY·Product code MUU·September 29, 2008

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 29, 2019

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

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