9 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
FDA Enforcement
Class II
·Terminated·Karl Storz Endovision, Inc.·April 13, 2016
Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·August 14, 2019
Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 8, 2016
Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·September 26, 2018