4 results
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10ms
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Sources: EU EUDAMED, US FDA
BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 24, 2014
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·July 23, 2014