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    Karl Storz Endoscopy-America, Inc.

    FDA registration
    Karl Storz Endoscopy-America, Inc.·220 products·🇺🇸 United States

    KARL STORZ ENDOSCOPY-AMERICA, INC.

    FDA registration
    KARL STORZ ENDOSCOPY-AMERICA, INC.·207 products·🇺🇸 United States

    KARL STORZ ENDOSCOPY-AMERICA, INC.

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KARL STORZ ROTOCUT MORCELLATOR

    FDA Adverse Event
    Malfunction ·KARL STORZ GMBH & CO.·Product code GCJ·June 18, 2014

    KARL STORZ

    FDA Adverse Event
    Death ·KARL STORZ GMBH & CO.·Product code FED·April 26, 1999

    KARL STORZ MORCELLATOR

    FDA Adverse Event
    Injury ·KARL STORZ GMBH & CO. KG·Product code GCJ·October 1, 2014

    SNOWDEN PENCER

    FDA Adverse Event
    Other ·CAREFUSION 2200, INC.·Product code GEI·March 29, 2024

    KARL STORZ ENDOSCOPY-AMERICA, INC.

    FDA Adverse Event
    Malfunction ·KARL STORZ ENDOSCOPY-AMERICA, INC.·Product code FJL·August 19, 2020

    KARL STORZ ENDOSCOPY AMERICA INC

    FDA Adverse Event
    Injury ·KARL STORZ ENDOSCOPY AMERICA, INC.·Product code FFK·May 8, 2003

    N.A.

    FDA Adverse Event
    Malfunction ·KARL STORZ GMBH CO. KG·Product code FCW·May 11, 2022

    KARL STORZ ENDOSCOPY-AMERICA, INC STORZ SHEATH

    FDA Adverse Event
    Injury ·KARL STORZ ENDOSCOPY-AMERICA, INC·Product code FJL·March 12, 2008

    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

    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

    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 Recall
    Terminated ·Karl Storz Endoscopy·Product code NKC·October 10, 2017

    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

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

    OLYMPUS LAPAROSCOPIC

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code GCJ·November 30, 2012

    CLICKLINE

    FDA Adverse Event
    Malfunction ·KARL STORZ ENDOSCOPY-AMERICA, INC.·Product code GEI·December 28, 2016

    PROTOSCOPES, SIGMOIDOSCOPES, ACC.

    FDA Adverse Event
    Malfunction ·KARL STORZ ENDOSCOPY-AMERICA, INC.·Product code FAM·November 14, 2016