BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    Xpan Universal Trocar System

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

    Wrist Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357235629·

    FLOWER SMALL AND MEDIUM BONE IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO CLASSIC GREAT TOE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLID SCREWDRIVER, SMALL

    FDA Adverse Event
    Malfunction ·CONVENTUS FLOWER ORTHOPEDICS·Product code HXX·August 17, 2021

    SMALL POSTERIOR AUGMENT GLENOID PLATE, RIGHT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·October 10, 2022

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·August 25, 2011

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 4, 2014

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026