7 results
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6ms
·
Sources: EU EUDAMED, US FDA
Multitom RAX with software version VF10
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 9, 2021
20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
FDA Enforcement
Class II
·Terminated·Western / Scott Fetzer Company·July 2, 2014
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
FDA Enforcement
Class II
·Terminated·Churchill Medical Systems, Inc.·March 13, 2013
Pathfast D-Dimer, Reference number: PF1051-KUS
FDA Enforcement
Class II
·Terminated·Lsi Medience Corporation·November 30, 2016
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
FDA Enforcement
Class II
·Terminated·VGI Medical, LLC·June 13, 2018
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
FDA Enforcement
Class II
·Terminated·RGI Medical Manufacturing, Inc.·July 16, 2014