KARL STORZ Endoscopy-America, Inc.
KARL STORZ Endoscopy-America, Inc. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2026, with 17 FDA device recalls on record.
Name variants for KARL STORZ Endoscopy-America, Inc.
as filed with FDA- KARL STORZ Endoscopy-America, Inc.
- Karl Storz Endoscopy America, Inc.
- Karl Storz-Endoscopy-America, Inc.
- Karl Storz Endoscopy_America, Inc.
Top product codes for KARL STORZ Endoscopy-America, Inc.
FDA recalls by KARL STORZ Endoscopy-America, Inc.
10 most recent of 17- Z-0527-2014 — 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.
- Z-0526-2014 — 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.
- Z-0465-2014 — Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
- Z-1728-2013 — 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.
- Z-1216-2013 — 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.
- Z-1314-2013 — Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
- Z-1308-2013 — Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
- Z-1316-2013 — Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
- Z-1315-2013 — Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
- Z-1307-2013 — Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by KARL STORZ Endoscopy-America, Inc.
1–100 of 362- K252624 — KARL STORZ Laryngoscopes and Accessories
- K240506 — KARL STORZ Holders
- K223885 — HOPKINS Telescopes
- K230359 — KOH Ultramicro Injection Cannula (26167NN) +11 more
- K223520 — UNIDRIVE SIII System
- K223923 — HOPKINS Telescopes
- K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable
- K221004 — HOPKINS Telescopes
- K222504 — H1
- K213194 — HD Mediastinoscope
- K221174 — Telepack +
- K212476 — KARL STORZ Flexible HD Cysto-Urethroscope System
- K203198 — KARL STORZ Metal Sterilization Trays
- K202272 — HD Mediastinoscope
- K203572 — Karl Storz Radel Sterilization Trays
- K201945 — KARL STORZ UDEL Sterilization Trays
- K200965 — XR-MX/1000
- K202925 — KARL STORZ ICG Imaging System
- K202957 — Flexible Video Cysto-Urethroscope (C-view)
- K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
- K201135 — Image1 S CCU, Image1 S 4U Camera Head
- K201399 — HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
- K200740 — HD Video Rhino Laryngoscope
- K201096 — CO2mbiLED
- K193235 — Telepack +
- K191357 — Flexible HD Cysto-Urethroscope System
- K182723 — Flexible HD Cysto-Urethroscope System
- K182186 — CMOS Video-Rhino-Laryngoscope System
- K183264 — Flex-THOR scope
- K182696 — Telepack X LED
- K180977 — KARL STORZ New Generation Trocars
- K180146 — KARL STORZ ICG Imaging System
- K171402 — KARL STORZ Slim Nasopharyngolaryngoscope
- K171717 — AUTOCON III 400
- K162992 — Karl Storz UROMAT E.A.S.I.
- K171238 — KARL STORZ ICG Imaging System
- K170462 — KARL STORZ ShuntScope
- K162880 — TIPCAM 1S 3D System
- K161554 — ENDOFLATOR 40, ENDOFLATOR 50
- K162410 — TIPCAM 1S 3D System
- K162882 — KARL STORZ ICG Imaging System
- K161555 — KARL STORZ NAV1 Electromagnetic Navigation System
- K161112 — KARL STORZ Flexible Video-Neuro-Endoscope System
- K152583 — KARL STORZ Endoscopic ICG Imaging System
- K160044 — Image1 SPIES System
- K150969 — Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
- K150525 — SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
- K151044 — CLICKLINE Scissor Insert for Single Use
- K143640 — KSEA CMOS Camera System (C-cam)
- K142556 — Flexible Video-Uretero-Choledochoscope System
- K140964 — CALCULASE II
- K141250 — FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
- K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
- K131953 — IMAGE1 SPIES
- K131369 — FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
- K122983 — KSEA BIPOLAR ELECTRODE
- K123956 — POWER LED 175
- K122096 — KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
- K103467 — CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
- K120769 — MODULTH SLK
- K111997 — IMAGE1 GI CCU MODEL 22203020-114
- K111165 — KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
- K112480 — VIEW 1 IMAGING
- K103308 — AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE
- K093054 — SCALP DURA RETRACTOR, MODEL KS00474
- K093471 — KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
- K093603 — STORM-BASE 2.0
- K091968 — KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
- K090818 — KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
- K083598 — KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
- K080852 — KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
- K071754 — NEO-VAGINA SURGERY SET AND ACCESSORIES
- K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 20132620
- K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
- K072410 — KSEA CLEARVISION II, MODEL 40334120
- K080410 — KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
- K072788 — STORZ MODULITH LITHOTRIPTER SLX-F2-F180
- K072387 — KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
- K071437 — MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
- K070579 — STORZ SLX-F2 STORM TOUCH
- K071530 — KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
- K070716 — IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
- K070827 — KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120
- K070752 — KSEA MINIATURE ENDOSCOPE, MODEL 11565
- K062464 — MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR
- K063585 — KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
- K062918 — KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
- K060907 — KARL STORZ VIDEO GASTROSCOPES
- K061180 — KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
- K052680 — CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
- K053262 — KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
- K052159 — AIDA COMPACT II SYSTEM
- K051972 — KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
- K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX
- K043324 — AIDA WITH DICOM AND HL7 INTERFACE
- K041912 — SCB/VALLEYLAB FORCE FX INTERFACE UNIT
- K040476 — STORZ MODULITH, MODEL SLX-F2
- K031457 — ENDOMAT LC PUMP, MODEL 20 3303 20
- K033728 — TRANSVAGINAL ENDOSCOPY SET
- K022490 — KSEA MEDI PACK
Data sourced from openFDA. This site is unofficial and independent of the FDA.