Precision BioLogic is registered with the FDA and our CRYOcheck medical devices are listed with the FDA as part of our registration. Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the United States’ ability to prepare for and respond to public health emergencies.
For more information on the FDA’s “Device Registration and Listing” requirements, please visit: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/default.htm.
You can search the FDA’s Establishment Registration & Device Listing database online at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm.