5,042 results
·
84ms
·
Sources: EU EUDAMED, US FDA
SINGLE USE ELECTROSURGICAL KNIFE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code KNS·March 17, 2021
OLYMPUS ELECTROSURGICAL UNIT
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·May 31, 2012
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 31, 2021
THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·April 24, 2014
THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·April 24, 2014
OLYMPUS CYLINDER HOSE FOR UHI-3
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code CCW·December 30, 2010
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 2020
EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code PSV·January 5, 2021
EVIS EXERA III VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·February 5, 2021
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·April 20, 2021
SONOSURG SCISSORS 5MM O.D., HF SERIES
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·December 19, 2014
SONOSURG SCISSORS 5MM O.D., HF SERIES
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·December 19, 2014
HD 3CMOS AUTOCLAVABLE CAMERA HEAD
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code OWN·March 19, 2021
THUNDERBEAT 5MM 35CM PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·April 24, 2014
HIGH FLOW INSUFFLATION UNIT
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code HIF·April 19, 2021
JAWS "HIQ+", 5 X 330 MM, JOHANN LONG
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCJ·August 8, 2017
OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·December 18, 2012
SINGLE USE 3-LUMEN SPHINCTEROTOME V
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code KNS·April 14, 2021
SONOSURG-G2
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·November 19, 2013
JAWS "HIQ+", 5 X 330 MM, JOHANN LONG
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCJ·July 28, 2017