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

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    MOZI TPS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ryno Lacer II Long

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357237241·

    DURALOC

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295106678·DURALOC SCREW-IN TRIAL LINER 28mm ID 64mm OD NE...

    DERMISEB CREAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RIATA PASSIVE FIXATION

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

    COLLEAGUE

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

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 12, 2013

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 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