18 results
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42ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
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
Electrode, Barrel Bar, 24FR (27050NX/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, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
FDA Enforcement
Class II
·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013
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
KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
FDA Enforcement
Class II
·Terminated·Karl Storz Endoscopy America Inc·May 15, 2013