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Karl Storz-Endoscopy-America, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest FDA decision2023-04-27
TypeNumberDevice NameCodeDateActions
510(k) K223520 UNIDRIVE SIII SystemHIH2023-04-27 View
510(k) 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 HeadOWN2020-08-17 View