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RETRACTION: A Faster CO₂ Fractional Scanner System Mode for Skin Rejuvenation: A Clinical Study. [PDF]

Skin Res Technol
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RETRACTION: Assessment of the Efficacy of 595 Nm Pulsed Dye Laser in the Management of Facial Flat Angiomas: Results of a Case Series. [PDF]

Skin Res Technol
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RETRACTION: High-Powered 675-nm Laser: Safety and Efficacy in Clinical Evaluation and In Vitro Evidence for Different Skin Disorders. [PDF]

Skin Res Technol
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WHOOP, There It Is: Lessons From WHOOP's FDA Warning Letter.

J Med Internet Res
Karow B.
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Performance Standards for Medical Device Approvals

Archives of Otolaryngology - Head and Neck Surgery, 1995
As a result of the controversy concerning the safety of silicone and other permanent implants, the Food and Drug Administration's Center for Drug Evaluation and Research has conducted a rereview of a small sample of applications by manufacturers. The Food and Drug Administration's "Final Report of the Committee for Clinical Review" found that clinical ...
F H, Silver, A I, Glasgold
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FDA-Approved Densitometry Devices

2003
The devices discussed in this chapter are available in the United States for clinical use. The specifications were provided by the manufacturers and are subject to change without notice as devices are continually upgraded to reflect advances in the technology. The categories of information provided by each manufacturer may vary slightly. All categories
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Drug and Device Approval Highlights from 2001

The Nurse Practitioner, 2002
The U.S. Food and Drug Administration approved more than 100 drugs and devices in 2001. This article discusses several of the new approvals, including ophthalmic drugs, contraceptive therapies, mental health medications, and medical devices.
Deborah, Kupecz, Candace, Berardinelli
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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
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