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

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

    AXIOM Artis dTC, Model Number 7413078

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021

    MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·January 31, 2018

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·February 12, 2014

    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·July 30, 2014

    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·November 13, 2013

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Single Detector (Stitching Patient Support) 712020

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    CombiDiagnost R90 (Stitching Patient Support) 709030

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Dual Detector (Stitching Patient Support) 712022

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Release 3 (Stitching Patient Support) 712025

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018