BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    BD Vaginal Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD POSIFLUSH¿ SALINE SYRINGE FILLED

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·March 26, 2019

    SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)

    FDA 510(k)
    FDA Class 2 ·Dental

    MAXONE IV FLUID/BLOOD WARMER, MODEL 102

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·August 25, 2011

    ALLERETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·October 31, 2014

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 10, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026