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Obstetrics/Gynecology devices

180 product codes reviewed by the Obstetrics/Gynecology panel. 4,633 510(k) clearances and 812 recalls in the FDA data, 43% of those recalls name a 510(k).

104510(k)s in 12 months
114recalls in 12 months
351recalls that name a 510(k)

Active product codes, Class I

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
LHQSystem, Telethermographic (Adjunctive Use)110

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