BEUDAMED
    11 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    Cios care fusion system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 17, 2019

    Cios Alpha VA20/ VA30 mobile X-Ray systems

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 17, 2019

    Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)

    FDA Enforcement
    Class II ·Terminated·Haemonetics Corporation·July 6, 2022

    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·November 14, 2018

    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

    FDA Enforcement
    Class II ·Terminated·AAP Implantate Ag·April 15, 2020

    The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets bind and aggregate fibrinogen-coated beads. The instrument measures this change in optical signal and reports results in P2Y12 Reaction Units (PRU). The rate of microbead aggregation is more rapid and reproducible if platelets are activated; therefore, the reagent adenosine-5-diphosphate (ADP) is incorporated into the test channel to induce platelet activation. Prostaglandin E1 (PGE1) is included in the reagent mixture to increase the specificity of the PRU result to reflect P2Y12-mediated platelet aggregation. The reagents are formulated such to achieve reaction concentrations of 20 ¿M ADP and 22 nM PGE1. In a like manner, two other activators, iso-TRAP (Thrombin Receptor Activating Peptide) with PAR4-AP (PAR4-Activating Peptide) and fibrinogen-coated microparticles are incorporated into a second channel of the test device. The instrument measures the change in transmittance in this channel, calculates the baseline platelet function for the sample, and reports the percent inhibition result for the sample.

    FDA Enforcement
    Class II ·Terminated·Accriva Diagnostics, Inc.·June 1, 2022

    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.

    FDA Enforcement
    Class II ·Terminated·AAP Implantate Ag·March 27, 2019

    Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, INC·February 21, 2018

    Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 18, 2017

    INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425

    FDA Enforcement
    Class III ·Terminated·AAP Implantate Ag·January 1, 2020

    INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453

    FDA Enforcement
    Class III ·Terminated·AAP Implantate Ag·January 1, 2020