8 results
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10ms
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Sources: EU EUDAMED, US FDA
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
FDA Enforcement
Class III
·Terminated·DNA Genotek Inc.·September 30, 2020
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 29, 2015
MAS Omni Immune Controls
FDA Enforcement
Class III
·Terminated·Microgenics Corporation·July 2, 2014
MAS Omni Immune PRO Controls
FDA Enforcement
Class III
·Terminated·Microgenics Corporation·July 2, 2014
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·February 11, 2015
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2020
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