86 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·January 22, 2025
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x 5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·December 4, 2024
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·February 5, 2025