Femasys, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Femasys, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FemVue® Controlled Saline-Air Device (FSA-300), FemVue MINI Saline-Air Device, FemChec Controlled Saline-Air Device (FCD-250)
9
Total
9
Cleared
0
Denied
Femasys, Inc. has 9 FDA 510(k) cleared medical devices. Based in Suwanee, US.
Latest FDA clearance: Dec 2025. Active since 2009. Primary specialty: Obstetrics & Gynecology.
Browse the FDA 510(k) cleared devices submitted by Femasys, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Femasys, Inc.
9 devices
Cleared
Dec 15, 2025
FemVue® Controlled Saline-Air Device (FSA-300)
Obstetrics & Gynecology
76d
Cleared
Nov 22, 2024
FemVue MINI Saline-Air Device
Obstetrics & Gynecology
136d
Cleared
Sep 06, 2024
FemChec Controlled Saline-Air Device (FCD-250)
Obstetrics & Gynecology
86d
Cleared
Sep 22, 2023
FemaSeed Intratubal Insemination
Obstetrics & Gynecology
101d
Cleared
Dec 20, 2012
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF...
Obstetrics & Gynecology
111d
Cleared
Oct 12, 2011
FEMCHEC PRESSURE MANAGEMET DEVICE
Obstetrics & Gynecology
187d
Cleared
Apr 28, 2011
FEMVUE SALINE-AIR DEVICE
Obstetrics & Gynecology
86d
Cleared
Apr 07, 2010
FEMVUE CORNUAL BALLOON CATHETER
Obstetrics & Gynecology
30d
Cleared
Jun 23, 2009
FEMVUE(TM) CATHETER SYSTEM
Obstetrics & Gynecology
193d