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

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    AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...

    External Fixation

    FDA UDI
    Life Spine, Inc.·00190837033958·4.8mm Short Drill

    UCP MULTIPLE DRUG SCREEN TEST CUPS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER

    FDA 510(k)
    FDA Class 2 ·Immunology

    LUMAX 540 DR-T

    FDA Adverse Event
    Death ·BIOTRONIK SE & CO. KG·Product code MRM·July 18, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 17, 2013

    FREESTYLE

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 23, 2008

    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 13, 2020