359 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·May 10, 2017
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 20, 2019
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 8, 2017
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·February 10, 2016
Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·December 16, 2015
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 2015
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·December 21, 2016
Uretero-reno fiberscope URF-P6
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 1, 2018
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 17, 2020
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 26, 2020
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 14, 2019
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·July 5, 2017
Olympus JF-160F duodenoscopes (Model NumberJF-160F)
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 27, 2018
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 26, 2020
Uretero-reno fiberscope URF-P6RP6
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 1, 2018
Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 1, 2018
Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 20, 2019
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 20, 2019
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 27, 2018
A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 7, 2018