4 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020