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산부인과 식품의약국 장비 승인 및 회수 평가

PMID: 29653261 · 2018-04-10

S, h, e, e, n, a, , G, a, l, h, o, t, r, a, ;, , J, o, s, e, p, h, , M, a, u, r, i, c, e

학술지Journal of minimally invasive gynecology

연도2018-04-10

PMID29653261

초록

To evaluate and compare the recall rates of obstetric and gynecologic devices approved via the Food and Drug Administration's 510(k) and premarket approval (PMA) processes. A retrospective observational study (Canadian Task Force classification II-2). Clinical settings in the United States that use obstetric and gynecologic devices. Two thousand two hundred forty-nine Food and Drug Administration-approved obstetric and gynecologic devices that were recalled between November 1, 2002, and December

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