6 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
FDA Enforcement
Class II
·Completed·Aesculap Implant Systems LLC·July 27, 2022
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·August 17, 2022
Aeos Robotic Digital Microscope, Product Code: PV010
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·June 19, 2024
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·NEO METRICS, INC.·June 18, 2014
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
FDA Enforcement
Class II
·Terminated·Ceg Enterprises Llc·June 29, 2016
ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
FDA Enforcement
Class II
·Terminated·VEO DIAGNOSTICS, LLC·December 9, 2020