BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710071·GC Initial™ LF Powder Opaque OB2, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556705923·GC Initial™ LF Powder Opaque OB2, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867303577·Low Profile Screw, 1.0x7mm, Cortical, Ti

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011871007000·Standard Band, Tooth 47-46/36-37, Size 7

    HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Fluorescence Mode

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 8, 2010

    TECNIS 1 MULTIFOCAL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·December 12, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025