16 results
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12ms
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Sources: EU EUDAMED, US FDA
GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
FDA Enforcement
Class II
·Terminated·Gulf Fiberoptics, Inc.·July 25, 2012
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-140, 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-Q160, 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-H180, 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 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
Drop Arm Versamode"
FDA Enforcement
Class II
·Terminated·Gf Health Products·April 14, 2021
Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912
FDA Enforcement
Class II
·Terminated·GF Health Products, Inc·December 21, 2016
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).
FDA Enforcement
Class II
·Terminated·GF Health Products, Inc./d.b.a.Basic American Metal Products·September 24, 2014