BEUDAMED
    341 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    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

    GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    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

    GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG

    FDA Enforcement
    Class II ·Ongoing·Invacare Corporation·January 12, 2022

    TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·July 11, 2012

    Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·October 2, 2013

    GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.

    FDA Enforcement
    Class II ·Terminated·Atlas Spine, Inc.·September 5, 2012

    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

    FDA Enforcement
    Class II ·Terminated·Mermaid Medical A/S·July 29, 2015

    Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

    FDA Enforcement
    Class II ·Ongoing·Invacare Corporation·June 1, 2022

    Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016