BEUDAMED
    53 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Status: Terminated × Clear all

    Ingenuity Core Computed Tomography X-ray system, Model 728321

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    Brilliance ICT SP Computed Tomography X-ray system, Model 728311

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    IQon Spectral CT Computed Tomography X-ray system, Model 728332

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    Ingenuity Core 128 Computed Tomography X-ray system, Model 728323

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories·March 21, 2018

    Ingenuity CT Computed Tomography X-ray system, Model 728326

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

    FDA Enforcement
    Class III ·Terminated·SPINEART SA·December 4, 2019

    Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories·March 21, 2018

    SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.

    FDA Enforcement
    Class III ·Terminated·Sigma·July 25, 2012

    BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·July 10, 2013

    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.

    FDA Enforcement
    Class III ·Terminated·Pega Medical Inc.·May 27, 2020

    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

    FDA Enforcement
    Class III ·Terminated·Medtest Holdings, Inc.·July 5, 2017

    ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc·November 26, 2014

    MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.

    FDA Enforcement
    Class III ·Terminated·CooperSurgical, Inc.·November 18, 2015

    Brilliance iCT Computed Tomography X-ray system, Model 728306

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013