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

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    Panther Fusion AdV/hMPV/RV Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Ophthlamic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668115541·INFANT SPECULUM 4MM SOLID (10/BX)

    InTess L

    FDA UDI
    Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square

    N/A

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369337·BI-LATERAL CLAMP ASSEMBLY

    SYS*STIM 208 AND 208A

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BELLAFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL, INC.·Product code LMH·September 8, 2023

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·January 18, 2022

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·October 28, 2008

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 19, 2011

    EON

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FPA·January 4, 2022

    OMRIX PRESSURE REGULATOR

    FDA Adverse Event
    Other ·OMRIX BIOPHARMACEUTICALS LTD·Product code FMF·August 28, 2013

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 18, 2019

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012