BEUDAMED
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    G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 21, 2018

    Proteus 235 Proton Therapy System for cancer treatment.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·November 5, 2014

    Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found that this species has unique components that make it ideal for wounds.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·September 10, 2025

    EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·February 7, 2024

    Achilles Express Bone Sonometer

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 16, 2019

    Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·April 4, 2018

    Achilles Insight Bone Sonometer

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 16, 2019

    VACUETTE SAFELINK, REF: 450210

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One GmbH·January 15, 2025

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Enforcement
    Class II ·Terminated·BBI SOLUTIONS OEM LTD·November 2, 2016

    OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·January 18, 2017

    OEC UroView 2800, fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 31, 2016

    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·January 21, 2015

    InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·July 18, 2012

    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·January 21, 2015

    OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·July 25, 2012

    OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·July 25, 2012