BEUDAMED
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    TONOMETER, DIGITON

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00147811050·2G Narrow A3.5

    WEIGHTED SPORK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 46MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·April 30, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 10, 2012

    C-ARM

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2010

    Intera 1.5T Power/Pulsar, Model Number: 781105;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

    Intera 1.5T Power/Pulsar, Model Number: 781105;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025

    Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018

    Intera 1.5T Power/Pulsar

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·March 6, 2019

    Intera 1.5T Power/Pulsar, Magnetic Resonance System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 24, 2024

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LNH·March 16, 2018

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018