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Femasys, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K253403 FemVue® Controlled Saline-Air Device (FSA-300)LKF2025-12-15 View
510(k) K242002 FemVue MINI Saline-Air DeviceLKF2024-11-22 View
510(k) K241693 FemChec Controlled Saline-Air Device (FCD-250)LKF2024-09-06 View
510(k) K231730 FemaSeed Intratubal InseminationMQF2023-09-22 View
510(k) K122658 FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009PCF2012-12-20 View
510(k) K110993 FEMCHEC PRESSURE MANAGEMET DEVICELKF2011-10-12 View
510(k) K110288 FEMVUE SALINE-AIR DEVICELKF2011-04-28 View
510(k) K100662 FEMVUE CORNUAL BALLOON CATHETERLKF2010-04-07 View
510(k) K083690 FEMVUE(TM) CATHETER SYSTEMLKF2009-06-23 View
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