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

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    Dexcom G6 Continuous Glucose Monitoring (CGM) System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Wrist Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357239313·

    VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A

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

    OPTISENSE

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

    SHILEY LOW PRESSURE CUFFED

    FDA Adverse Event
    Injury ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·August 17, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·July 8, 2013

    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