510K Clearances

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

510K Clearances

PostPosted by DCNGA » Mon Apr 16, 2012 6:41 pm

If you know the name of the device that harmed you, you can go here to see the 510(k) clearance on the device:

http://www.fda.gov/MedicalDevices/Produ ... 089319.htm

Just put in the name of the device.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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