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

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    JM-102 JAUNDICE METER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MICROLUX/BLU

    FDA 510(k)
    FDA Class 1 ·Dental

    Endoscopic Ultrasound Aspiration Needle

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 30, 2010

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    FDA Adverse Event
    Malfunction ·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·February 15, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014

    TPRLC 133 FP TYPE1 PPS HO 17.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·April 6, 2023

    CER BIOLOXD OPTION HD 36MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·April 13, 2023

    Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems, Inc·Product code LGW·April 23, 2010

    Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.

    FDA Recall
    Terminated ·St. Jude Medical·Product code LGW·July 26, 2012

    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems Inc.·Product code MHY·March 28, 2012

    Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems Inc.·Product code LGW·December 19, 2011