BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPEEDTRAP

    FDA UDI
    Medos International Sàrl·10886705027132·SPEEDTRAP Graft Preparation System WHITE 20 mm

    Ryno Lacer II Short

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357237463·

    ZMS®

    FDA UDI
    Zimmer, Inc.·00889024039810·

    AMES THERAPY DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Venen-trainer (Model: FM150, SFM90)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPEEDTRAP WHITE 20MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code GAT·June 5, 2018

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 25, 2011

    UNKNOWN DEPUY PINNACLE METAL LINER

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ? REG. # 8010379·Product code KWA·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