BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS

    FDA 510(k)
    FDA Class 2 ·Immunology

    SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 13, 2014

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 18, 2010

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 2012

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026