BEUDAMED
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    Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 7, 2018

    This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.

    FDA Enforcement
    Class II ·Terminated·DJO, LLC·July 22, 2020

    Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·August 3, 2018

    Healix Knotless ADV BR 5.5 Suture Anchor

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·December 18, 2019

    Healix Knotless ADV BR 4.75 Suture Anchor

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·December 18, 2019

    Healix Knotless ADV BR 5.5 Suture Anchor

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·November 4, 2019

    Healix Knotless ADV BR 4.75 Suture Anchor

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·November 4, 2019

    AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnI) in human serum or plasma on the AxSYM System; list 2J44-22

    FDA Recall
    Terminated ·Abbott Laboratories·Product code MMI·January 19, 2009

    Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JJE·September 8, 2006

    Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IYB·December 8, 2003

    MagicView 1000 and Magic View Mondo. Digital Image Communication.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LMD·July 3, 2003

    Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.

    FDA Recall
    Terminated ·Mallinckrodt Inc·Product code DXT·April 14, 2008

    Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·November 20, 2013

    AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code MMI·April 23, 2007

    ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 7, 2018

    Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 7, 2018

    3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 29, 2018

    Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·August 6, 2018

    Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·August 6, 2018