29 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·September 5, 2018
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·December 11, 2024
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended 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.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 27, 2024
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·October 30, 2024
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 29, 2022
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