BEUDAMED
    14 results · 30ms · Sources: EU EUDAMED, US FDA

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    Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD BBL™ Levine EMB Agar

    FDA UDI
    BECTON, DICKINSON AND COMPANY·10382902211706·BD BBL™ Levine EMB Agar

    TriVerse Femoral Trial PS Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215097790·

    TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESIN 11

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 3, 2014

    AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·May 22, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 24, 2011

    9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·May 17, 2019

    XP-CR Tibial Tray - Interlok 71mm Item # 195273

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

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

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015