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

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    Digital ClarusScope System, Digital NeuroPEN System

    FDA 510(k)
    FDA Class 2 ·Neurology

    ASO Speed Lacer Ankle Stabilizer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357236152·

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044201208·15 mL Sterile Transport Vials with Caps

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044205428·TRANS VIAL W/CAP 15ML BRICK

    IRIS - HIGH STRENGTH GLASS CERAMIC

    FDA 510(k)
    FDA Class 2 ·Dental

    GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

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

    ZILVER PTX 35 DRUG-ELUTING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code NIU·October 30, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    UNKNOWN DEPUY BONE CEMENT

    FDA Adverse Event
    Injury ·9610921 DEPUY CMW·Product code LOD·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