BEUDAMED
    21 results · 15ms · Sources: EU EUDAMED, US FDA

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

    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·June 11, 2014

    Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·March 9, 2016

    The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 10, 2014

    Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·July 16, 2014

    Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·January 15, 2014

    Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·February 20, 2013

    Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 18, 2013

    Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·November 27, 2013

    Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·February 26, 2014

    Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·October 24, 2012

    ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·July 31, 2013

    Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 30, 2015

    Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 30, 2015

    Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·February 4, 2015

    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 30, 2015

    Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·January 6, 2016

    Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·March 6, 2013

    Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 25, 2013

    Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 30, 2015

    UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·October 30, 2013