BEUDAMED
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    PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

    FDA Recall
    Terminated ·Laurimed LLC·Product code ERL·April 7, 2014

    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

    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

    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

    Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

    FDA Enforcement
    Class III ·Terminated·Karl Storz Endoscopy·May 20, 2020

    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 Recall
    Terminated ·Karl Storz Endoscopy America Inc·Product code ECQ·November 13, 2013

    ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979

    FDA Recall
    Terminated ·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018

    ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656

    FDA Recall
    Terminated ·Orthofix Srl Via Delle Nazioni·Product code KTT·September 27, 2018

    ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603

    FDA Recall
    Terminated ·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018

    ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075

    FDA Recall
    Terminated ·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018

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

    FDA Recall
    Terminated ·Karl Storz Endoscopy America Inc·Product code FJL·June 1, 2009

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

    FDA Recall
    Terminated ·Karl Storz Endoscopy America Inc·Product code FJL·June 1, 2009

    ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922

    FDA Recall
    Terminated ·Orthofix Srl Via Delle Nazioni·Product code KTT·September 27, 2018

    ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901

    FDA Recall
    Terminated ·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018

    ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791

    FDA Recall
    Terminated ·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018

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

    FDA Recall
    Terminated ·Karl Storz Endoscopy America Inc·Product code FJL·June 1, 2009

    ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959

    FDA Recall
    Terminated ·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018