BEUDAMED
    23 results · 17ms · Sources: EU EUDAMED, US FDA

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

    STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·November 22, 2017

    27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·July 24, 2013

    Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·December 25, 2013

    Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral intubation " Transnasal intubation " Evaluation of placement of endotracheal and double lumen endotracheal tubes " Provide visual access to the larynx and tracheobronchial tree.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·December 25, 2013

    Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·July 16, 2014

    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·July 13, 2016

    Flexible Intubation Fiberscope, Model # 11301AB1

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·September 11, 2019

    FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·September 4, 2019

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·April 8, 2020

    Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013

    Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy America Inc·December 18, 2013