29 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
FDA Enforcement
Class II
·Terminated·Medtronic·December 28, 2016
Colonoscope, Model Number PCF-H190TL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
Colonoscope, Model Number PCF-H190L.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
Colonoscope, Model Number PCF-Q180AL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
Colonoscope, Model Number PCF-H190DL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
Colonoscope, Model Number PCF-H180AL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
Colonoscope, Model Number PCF-HQ190L.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016