BEUDAMED
    21 results · 32ms · Sources: EU EUDAMED, US FDA

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    Zhenjiang Assure Mechanical Wheelchair,model:K1

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517578747·CoRoent Ant TLIF Ti, 13x11x32mm 0°

    BD BBL™ Sensi-Disc™ Penicillin - 2 units

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902313206·BD BBL™ Sensi-Disc™ Penicillin 2 IU/IE/UI

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036689·2.0mm J-Latch FPS Drill, Short

    TP Original Wire

    FDA UDI
    TP ORTHODONTICS INC·00192029028827·Premier Round

    EK-PRO ARRHYTHMIA DETECTION ALGORITHM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1059020-2013-00008

    FDA Adverse Event
    Other ·May 13, 2013

    SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 1, 2020

    ENSITE CLASSIC SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

    OPTISENSE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014

    3002 SECURE II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 18, 2011

    ACTIVA

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code MHY·July 17, 2013

    VITEK 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

    SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·August 3, 2020

    SYR 0.3ML 30GA 8MM 7BAG 420CAS JP

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 29, 2020

    VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·June 21, 2017

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025