BEUDAMED
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    Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.

    FDA Enforcement
    Class II ·Ongoing·Arthrex, Inc.·December 14, 2022

    Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 8, 2019

    NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 8, 2019

    GE Healthcare Discovery NM/CT 670 CZT X-ray system

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 21, 2017

    Widefield OCT software feature for the Spectralis HRA+OCT and variants

    FDA Enforcement
    Class II ·Terminated·Heidelberg Engineering·May 2, 2018

    Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

    FDA Enforcement
    Class II ·Ongoing·Carl Zeiss Meditec, Inc.·August 18, 2021

    GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·January 20, 2021

    NM/CT 870 CZT Model # H3906CW

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 30, 2020

    The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·January 8, 2020

    CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

    FDA Enforcement
    Class II ·Ongoing·Carl Zeiss Meditec, Inc.·March 16, 2022

    GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025

    The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.).

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 28, 2013

    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine, Inc·April 5, 2017

    Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

    FDA Enforcement
    Class II ·Ongoing·Gentuity, LLC·April 22, 2026

    OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4

    FDA Enforcement
    Class II ·Ongoing·Haag-Streit USA Inc·January 19, 2022

    OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4

    FDA Enforcement
    Class II ·Ongoing·Haag-Streit USA Inc·January 19, 2022

    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·April 20, 2016

    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·June 1, 2016

    Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).

    FDA Enforcement
    Class II ·Terminated·Zimmer Spine, Inc.·March 9, 2016

    Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw

    FDA Enforcement
    Class II ·Terminated·ulrich medical USA Inc·March 4, 2020