A study released by Advanced Medical Technology Association (AdvaMed) reaffirms the safety record of FDAs premarket review process for low- and moderate-risk devices, known as the 510(k) process. The study, conducted by the research firm Battelle Memorial Institute for AdvaMed, demonstrates that of the nearly 47,000 medical devices cleared by FDA through the 510(k) process since 1998, only 0.16 percent were involved in a serious recall event.