7 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
FDA Enforcement
Class II
·Ongoing·Icotec Ag·December 28, 2022
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
VADER pedicle system, torque wrench, Catalog Number 42-702
FDA Enforcement
Class II
·Ongoing·Icotec Ag·January 17, 2024
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014
Vue Motion V12. Product Number: 1017979.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026