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

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    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems (Schweiz) Ag·September 18, 2013

    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code DYB·April 28, 2014

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·October 10, 2018

    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems (Schweiz) Ag·September 18, 2013

    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·May 21, 2014

    Ventstar Coax, MP03373

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZO·April 17, 2023

    ID Coax 180, MP03375

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZO·April 17, 2023

    Ventstar Coax 230, MP03376

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZO·April 17, 2023

    Ventstar Coax 180, MP03374

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZO·April 17, 2023

    VentStar Coax (P) 150, MP00379

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZO·April 17, 2023

    Anesthesia Set Coax 180, MP03384

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023

    Anesthesia Circuit Kit Coax 1, MP02730

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023

    Anesthesia Circuit Kit Coax HEPA, MP17102

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023

    Anesthesia Circuit Kit Coax 3, MP02732

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023

    Ventstar Coax, MP03373

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    Ventstar Coax 180, MP03374

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    Ventstar Coax 230, MP03376

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    ID Coax 180, MP03375

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    Anesthesia Set Coax 180, MP03384

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    VentStar Coax (P) 150, MP00379

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023