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Reuse of single-use Kahook dual blade: Safety and ethics. [PDF]
Mansoori T.
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FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications.
Zapotoczny G +5 more
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Performance Standards for Medical Device Approvals
Archives of Otolaryngology - Head and Neck Surgery, 1995As 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
2003The 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, 2002The 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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