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

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    SMALL BARD VENTRALEX PATCH

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

    Woven Phillips Follower Urethral Bougie

    FDA UDI
    C. R. Bard, Inc.·00801741073274·Woven Phillips Follower Urethral Bougie

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193107165·HA PEEK EVOS Straight, ,8mmx10mmx 22mm , BICONV...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0840080·Distractor, Screw to Screw

    STRESS GUARD, MODEL HERDEV1

    FDA 510(k)
    FDA Class 2 ·Neurology

    HEMOCHRON JR. CITRATE APTT CUVETTE

    FDA 510(k)
    FDA Class 2 ·Hematology

    PERMACOL

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·January 8, 2026

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 27, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 14, 2011

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·April 4, 2008

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·February 12, 2014

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code GFO·December 19, 2013

    Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No. FA-71300-25V09 FA-71350-25V16 FA-71400-25V10 FA-71425-35V13 FA-71475-30V16 FA-71300-25V12 FA-71350-25V17 FA-71400-25V11 FA-71425-35V15 FA-71475-30V18 FA-71300-25V13 FA-71350-25V18 FA-71400-25V12 FA-71425-35V18 FA-71475-35V09 FA-71300-25V15 FA-71350-25V19 FA-71400-25V13 FA-71450-25V09 FA-71475-35V10 FA-71300-25V16 FA-71350-30V09 FA-71400-25V15 FA-71450-25V10 FA-71475-35V11 FA-71300-25V17 FA-71350-30V10 FA-71400-25V16 FA-71450-25V11 FA-71475-35V12 FA-71300-25V18 FA-71350-30V12 FA-71400-25V18 FA-71450-25V12 FA-71475-35V13 FA-71300-25V19 FA-71350-30V13 FA-71400-25V19 FA-71450-25V13 FA-71475-35V15 FA-71300-30V09 FA-71350-30V15 FA-71400-30V09 FA-71450-25V15 FA-71475-35V18 FA-71300-30V12 FA-71350-30V16 FA-71400-30V10 FA-71450-25V16 FA-71475-35V19 FA-71300-30V13 FA-71350-30V18 FA-71400-30V11 FA-71450-25V18 FA-71500-25V09 FA-71300-30V15 FA-71350-35V09 FA-71400-30V12 FA-71450-25V19 FA-71500-25V10 FA-71300-30V16 FA-71350-35V10 FA-71400-30V13 FA-71450-30V09 FA-71500-25V11 FA-71300-30V19 FA-71350-35V12 FA-71400-30V15 FA-71450-30V10 FA-71500-25V12 FA-71300-35V09 FA-71350-35V13 FA-71400-30V16 FA-71450-30V11 FA-71500-25V13 FA-71300-35V12 FA-71350-35V15 FA-71400-30V18 FA-71450-30V12 FA-71500-25V15 FA-71300-35V13 FA-71350-35V18 FA-71400-35V09 FA-71450-30V13 FA-71500-25V16 FA-71300-35V15 FA-71375-25V09 FA-71400-35V13 FA-71450-30V15 FA-71500-25V18 FA-71325-25V09 FA-71375-25V10 FA-71400-35V15 FA-71450-30V16 FA-71500-25V19 FA-71325-25V10 FA-71375-25V11 FA-71400-35V18 FA-71450-30V18 FA-71500-30V09 FA-71325-25V12 FA-71375-25V12 FA-71425-25V09 FA-71450-30V19 FA-71500-30V10 FA-71325-25V13 FA-71375-25V13 FA-71425-25V10 FA-71450-35V09 FA-71500-30V11 FA-71325-25V15 FA-71375-25V15 FA-71425-25V11 FA-71450-35V10 FA-71500-30V12 FA-71325-25V18 FA-71375-25V16 FA-71425-25V12 FA-71450-35V12 FA-71500-30V13 FA-71325-25V19 FA-71375-25V17 FA-71425-25V13 FA-71450-35V13 FA-71500-30V15 FA-71325-30V09 FA-71375-25V18 FA-71425-25V15 FA-71450-35V15 FA-71500-30V16 FA-71325-30V10 FA-71375-25V19 FA-71425-25V16 FA-71450-35V16 FA-71500-30V17 FA-71325-30V12 FA-71375-30V09 FA-71425-25V18 FA-71475-25V09 FA-71500-30V18 FA-71325-30V13 FA-71375-30V10 FA-71425-25V19 FA-71475-25V10 FA-71500-35V09 FA-71325-30V15 FA-71375-30V12 FA-71425-30V09 FA-71475-25V11 FA-71500-35V10 FA-71325-30V16 FA-71375-30V13 FA-71425-30V10 FA-71475-25V12 FA-71500-35V11 FA-71325-30V18 FA-71375-30V15 FA-71425-30V11 FA-71475-25V13 FA-71500-35V12 FA-71325-30V19 FA-71375-30V16 FA-71425-30V12 FA-71475-25V15 FA-71500-35V13 FA-71325-35V09 FA-71375-30V18 FA-71425-30V13 FA-71475-25V16 FA-71500-35V15 FA-71325-35V12 FA-71325-35V13 FA-71325-35V15 FA-71350-25V09 FA-71350-25V10 FA-71350-25V13 FA-71350-25V15 FA-77250-10V13 FA-77250-10V19 FA-77250-12V11 FA-77250-12V12 FA-77250-12V13 FA-77250-12V18 FA-77250-14V12 FA-77250-14V13 FA-77250-14V15 FA-77250-14V18 FA-77250-14V19 FA-77250-16V11 FA-77250-16V12 FA-77250-16V13 FA-77250-16V15 FA-77250-16V16 FA-77250-16V19 FA-77250-18V09 FA-77250-18V10 FA-77250-18V11 FA-77250-18V12 FA-77250-18V13 FA-77250-18V16 FA-77250-18V18 FA-77250-18V19 FA-77250-20V10 FA-77250-20V11 FA-71375-35V09 FA-71375-35V12 FA-71375-35V13 FA-71375-35V15 FA-71375-35V16 FA-71375-35V18 FA-71400-25V09 FA-77275-14V11 FA-77275-14V12 FA-77275-14V13 FA-77275-14V17 FA-77275-14V18 FA-77275-14V19 FA-77275-16V12 FA-77275-16V13 FA-77275-16V16 FA-77275-16V18 FA-77275-16V19 FA-772

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018