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

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    Mimics Enlight CMF

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIRVANA D PERSONAL LUBRICANT (TBD)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SIGMA PLI XLK INS 6 8MM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JWH·May 30, 2023

    ATLAS II PLUS DR

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

    MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) KIT

    FDA Adverse Event
    Injury ·KIMBERLY-CLARK HEALTH CARE·Product code KNT·August 25, 2011

    OT PING METER

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