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

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    Filters Classification: Class I × Regulation: Us FDA × Clear all

    SHERPA NX ACTIVE GUIDING CATHETER, 6F RELAXED MOD HSII, .070", REF SA6RMHSII. for cardiovascular use

    FDA Enforcement
    Class I ·Completed·Medtronic Vascular·October 9, 2019

    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·May 22, 2024

    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·May 22, 2024

    OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.

    FDA Enforcement
    Class I ·Terminated·Hummingbird Med·July 13, 2016

    ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.

    FDA Enforcement
    Class I ·Terminated·Hummingbird Med·June 1, 2016

    DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018