BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    BIRTCHER SURE CLEAN INSTRUMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BR Surgical, LLC

    FDA UDI
    BR Surgical, LLC·00857556008321·Hysteroscope, autoclavable, Ø 2.9mm, 30º, 302mm

    HBS HEADLESS BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEGASUTURECUT NEEDLE DRIVER

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·January 25, 2013

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 24, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 11, 2014

    1 SURGILENE

    FDA Adverse Event
    Injury ·DAVIS & GECK, INC.·Product code GAW·October 25, 1995

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

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