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

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    Blood Collection Needle (with/without Needle Holder)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    1CC FUTURA SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    DURATA STS OPTIM ACTIVE FIXATION

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

    OT ULTRALINK METER

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

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·November 14, 2016

    UNKNOWN SALINE IMPLANTS SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·July 2, 2024

    UNKNOWN SALINE IMPLANTS SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·July 2, 2024

    PRODIGY AUTOCODE

    FDA Adverse Event
    Malfunction ·OK BIOTECH CO., LTD.·Product code NBW·May 7, 2026

    PRODIGY AUTOCODE

    FDA Adverse Event
    Malfunction ·OK BIOTECH CO., LTD.·Product code NBW·February 3, 2026

    PRODIGY AUTOCODE

    FDA Adverse Event
    Malfunction ·OK BIOTECH CO., LTD.·Product code NBW·March 5, 2026

    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