Device Reproductive Toxicity Evaluation Method

Evaluating a device for chemicals or other agents that may have caused problems with the reproductive system. This includes evaluating a device for chemicals or agents that may have caused or contributed to birth defects or malformations (teratogenic evaluation). (Food and Drug Administration)

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Device Reprocessed Code

A coded value specifying whether a device is reconditioned.

Device Repaired and Returned Evaluation Conclusion

The device was repaired and returned to the user (reporter) following a reported device problem.

Device Reactivity Testing Evaluation Method

Testing the device for problems related to how the materials react to other factors (e.g. over-react or under-react).

Device Reactivity Problem Evaluation Result

A device problem related to how the materials react inappropriately (e.g. over-react or under-react).

Device Radiologic Evaluation Method

Evaluating the safety provisions in a device used for medical imaging, i.e., if the device can cause injury to individuals during imaging…

Device Radiographic Problem Evaluation Result

Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging, etc.