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

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    Little Wave Arc; Little Wave Flip

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ENDER NAIL

    FDA UDI
    Smith & Nephew, Inc.·03596010104458·3.5MM DIAMETER NAIL 3.5MMX33CM ...

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044201154·Sterile 30 mL Freestanding w/Spork Centrifuge T...

    VASSALLO GT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BARCO MEDIS 5MP2 AURA

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 4, 2014

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·August 25, 2011

    FLEXTEND

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

    VASSALLO GT

    FDA Adverse Event
    Injury ·FILMECC CO., LTD.·Product code DQX·October 3, 2024

    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