Results 191 to 200 of about 315,340 (245)

Orthopaedic Device Approval Through the Premarket Approval Process

Journal of Bone and Joint Surgery, 2017
Abstract: The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device.
Brian W, Yang, Matthew L, Iorio, Charles S, Day   +2 more
openaire   +2 more sources

New Humanitarian Device Approval

Biomedical Safety & Standards, 2003
openaire   +2 more sources

Integrative oncology: Addressing the global challenges of cancer prevention and treatment

Ca-A Cancer Journal for Clinicians, 2022
Jun J Mao,, Msce, Lorenzo Cohen, Karen M Mustian   +2 more
exaly  

Comparison of CE approved TEVAR devices.

The Journal of cardiovascular surgery, 2010
The indications for endovascular therapy of thoracic aortic pathologies are expanding. The complexity of cases is increasing. The individual anatomy and pathology of the thoracic aorta alone and in combination create specific difficulties in stent graft delivery, deployment, and fixation.
M, Gawenda, J, Brunkwall
openaire   +1 more source

Device Approval

JAMA, 2011
openaire   +1 more source

New Lancing Device Approved

Journal of Clinical Engineering, 2003
openaire   +2 more sources

FDA device approval regulations

Human Pathology, 1994
openaire   +1 more source

New Device Approvals

Biomedical Safety & Standards, 2007
openaire   +1 more source

Speeding Device Approval

JAMA, 2012
openaire   +1 more source

FDA Approves New Devices

Journal of Clinical Engineering, 2011
openaire   +1 more source