BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ATRAMAT

    FDA UDI
    Internacional Farmacéutica, S.A. de C.V.·07500142080531·ATRAMAT SILK SURGICAL SUTURE BLACK USP 3-0 EP 2...

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QJR·April 6, 2023

    IPL THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDS-4 NEUROMUSCULAR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 4, 2014

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 17, 2011

    ENDOVIVE? LOW PROFILE REPLACEMENT BUTTON

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·July 12, 2013

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

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