BEUDAMED
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    Chisel, Middle-Ear

    FDA classification
    FDA Class 1 ·Chisel, Middle-Ear

    Device, Inflation, Middle Ear

    FDA classification
    FDA Unclassified ·Device, Inflation, Middle Ear

    GE Proteus XR/A radiographic system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare (China) Co., Ltd.·December 4, 2024

    Bur, Ear, Nose And Throat

    FDA classification
    FDA Class 1 ·Bur, Ear, Nose And Throat

    Cement, Ear, Nose And Throat

    FDA classification
    FDA Class 2 ·Cement, Ear, Nose And Throat

    Pierced Ear/Entry Cleaning Tray

    FDA classification
    FDA Class 1 ·Pierced Ear/Entry Cleaning Tray

    Ear, Nose, And Throat Image Analyzer

    FDA classification
    FDA Class 2 ·Ear, Nose, And Throat Image Analyzer

    Ear, Nose, And Throat Surgical Tray

    FDA classification
    FDA Class 1 ·Ear, Nose, And Throat Surgical Tray

    Ear, Nose, And Throat Stereotaxic Instrument

    FDA classification
    FDA Class 2 ·Ear, Nose, And Throat Stereotaxic Instrument

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    FDA classification
    FDA Class 3 ·Implant, Hearing, Active, Middle Ear, Totally Implanted

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    FDA classification
    FDA Class 3 ·Implant, Hearing, Active, Middle Ear, Partially Implanted

    Polymer, Ear, Nose And Throat, Synthetic, Absorbable

    FDA classification
    FDA Class 2 ·Polymer, Ear, Nose And Throat, Synthetic, Absorbable

    Early Growth Response 1 (Egr) Fish Probe Kit

    FDA classification
    FDA Class 2 ·Early Growth Response 1 (Egr) Fish Probe Kit

    Device System, Imaging, Tympanic Membrane And Middle Ear

    FDA classification
    FDA Class 2 ·Device System, Imaging, Tympanic Membrane And Middle Ear

    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·NEUSOFT MEDICAL SYSTEMS IMP & EX·February 13, 2019

    Media, Culture, Ex Vivo, Tissue And Cell

    FDA classification
    FDA Class 2 ·Media, Culture, Ex Vivo, Tissue And Cell

    GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare (China) Co., Ltd.·September 4, 2024