6 results
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7ms
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Sources: EU EUDAMED, US FDA
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·November 14, 2018
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·QIAGEN·August 8, 2018
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
FDA Enforcement
Class II
·Terminated·Smith & Nephew Inc.·March 5, 2014
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Enforcement
Class II
·Terminated·Dental EZ Stardental Division·June 19, 2013
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
FDA Enforcement
Class II
·Terminated·Dental EZ Group Star Dental Division·July 23, 2014