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

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    DALI SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AONGEN DENTAL COLLAGEN MATRIX

    FDA 510(k)
    FDA Unclassified ·Unknown

    MODEL SB100II FINGER PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICRONY II SR+

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014

    DXTEND GLENOSPHERE ECC D38MM

    FDA Adverse Event
    Injury ·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code HSD·May 21, 2013

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 2, 2011

    DANTEC CONCENTRIC NEEDLE ELECTRODE

    FDA Adverse Event
    Injury ·NATUS MANUFACTURING LTD.·Product code IKT·December 10, 2018

    Artis Q biplane, Model Number 10848282

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014