Product code OWN— Gastroenterology, Urology
KARL STORZ ICG Imaging System
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 61
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OWN
- K242163 — SmartSurgN Visualization System
- K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens
- K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
- K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040)
- K260108 — L12 LED Light Source with AIM
- K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
- K243711 — Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
- K243591 — OPTOVISION Endoscopic Light Source Unit
- K241275 — Histolog® Scanner (Hardware 2.4, Software 3.3)
- K233333 — KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
- K232857 — KARL STORZ ICG Imaging System
- K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
- K231344 — ActivSight Intraoperative Imaging System
- K230407 — FloNavi Open Field Fluorescence Imaging System
- K230754 — L12 LED Light Source with AIM
- K213943 — SmartSurgN Visualization System
- K223020 — VS3-Iridium System (VS3-IR)
- K221611 — 780 nm L11 LED Light Source with AIM
- K220477 — Cellvizio 100 series system with confocal Miniprobes
- K210265 — VS3 Iridium Sytem
- K212695 — KARL STORZ ICG Imaging System
- K212322 — Cellvizio I.V.E. system with Confocal Miniprobes
- K203550 — ActivSight Intraoperative Imaging System
- K202925 — KARL STORZ ICG Imaging System
- K202244 — SPY-PHI System with SPY-PHI Fluorescence Assessment Software
- 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
- K200542 — Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
- K200737 — SPY Portable Handheld Imaging (SPY-PHI) System
- K193416 — Cellvizio I.V.E. with Confocal Miniprobes
- K191144 — Cellvizio 100 Series System with Confocal Miniprobes
- K191851 — VS3-IR
- K192292 — L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
- K192174 — SPY Portable Handheld Imaging (SPY-PHI) System
- K191046 — L10 LED Light Source with AIM, L11 LED Light Source with AIM
- K190729 — SPY Portable Handheld Imaging (SPY-PHI) System
- K183453 — VS3-IR
- K183640 — Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
- K173866 — Stryker AIM Light Source and SafeLight cable
- K172844 — Cellvizio 100 Series System with Confocal Miniprobes
- K171345 — Cellvizio 100 Series Systems with Confocal Miniprobes
- K171238 — KARL STORZ ICG Imaging System
- K162882 — KARL STORZ ICG Imaging System
- K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System
- K152583 — KARL STORZ Endoscopic ICG Imaging System
- K160416 — CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
- K150831 — Cellvizio 100 Series System with Confocal Miniprobes
- K152204 — VS3-IR system
- K151593 — Cellvizio 100 Series System with Confocal Miniprobes
- K143474 — Artemis Hand Held Imaging System
- K150018 — VS3-IR-MMS System
- K142310 — Stryker Infrared Fluorescence (IRF) Imaging System
- K141358 — CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
- K133466 — CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
- K132475 — FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
- K132389 — CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED
- K124031 — DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
- K123676 — CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
- K122042 — CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
- K120208 — CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
- K110480 — PDE PHOTODYNAMIC EYE
- K111047 — CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
Data sourced from openFDA. This site is unofficial and independent of the FDA.