BEUDAMED
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    ADHESIVE REMOVER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    POLARIS Q-SWITCH RUBY SYSTEM

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

    AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED

    FDA 510(k)
    FDA Class 2 ·Hematology

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·September 30, 2024

    PERITONEAL CATHETER WITH BIOGLIDE, STANDARD, TRANSLUCENT, 90 CM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·May 20, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 25, 2012

    LIGASURE V 5 MM SEALER DIVIDER

    FDA Adverse Event
    Injury ·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 20, 2010

    Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 28, 2025

    Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 6, 2025

    Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 30, 2025

    Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 13, 2025

    Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024