deem the device substantially equivalent and issue a clearance letter; • deem the device not substantially equivalent (NSE) and issue an NSE letter, which prohibits marketing of the device; • request additional information (with the final clearance decision pending review of that information). ...
ArticlePubMedCASGoogle Scholar Lu B, Wu Y, Nielson CM, Flores R, Abrahamsen M, Papenfuss M, Harris RB, Giuliano AR. Factors associated with acquisition and clearance of human papillomavirus infection in a cohort of US men: a prospective study. J Infect Dis. 2009;199:362–71. ArticlePubMed...
Evaluation of nasal mucociliary clearance after medical or surgical treatment of chronic rhinosinusitis. Eur Arch Otorhinolaryngol 2009 Sep;266(9): 1423-1426.Naxakis S, Athanasopoulos I, Vlastos IM, Giannakenas C, Vassilakos P, Goumas P (2009) Evaluation of nasal mucociliary clearance after ...
After surgical evaluation, it was decided to try to reduce the defect by performing reconstructive surgery. This procedure resulted in two wounds measuring 20.75 cm2 and 9.17 cm2, respectively. The result of the FiV-FeLv rapid test was positive and the bacteriological examination from the wound ...
Several transvaginal mesh devices were approved through the FDA's510(k) clearance process, which allowed products to enter the market without rigorous clinical testing. While the ProteGen mesh was recalled after three years, other devices based on its design remain available today. ...
The FDA has regulated medical devices since 1976. The agency classifiesmedical devicesbased on the potential risk they pose. Class I devices are the least risky and include things like surgical tools and oxygen masks. Medical devices that are listed as Class III are considered the most risky dev...
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Catheter-based or surgical procedure Indications: Hemodynamically unstable patients with massive emboli, who are not suitable candidates for thrombolytic therapy (e.g., active bleeding) In cases of failed thrombolytic therapyPrognosis assessment[2,29]Patients...
Letter: Creatinine clearance: bedside estimate. Ann Intern Med. 1973 Oct;79(4):604-5. PubMed ID: 4748282 Jenkins CD, Stanton BA, Niemcryk SJ, Rose RM. A scale for the estimation of sleep problems in clinical research. J Clin Epidemiol. 1988;41(4):313-21. PubMed ID: 3351539 Ji...