FDA.reportPublic FDA data

Vaginal dilator

Definition
A firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.
GUDID devices
800
Last updated
2026-06-05 06:05:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04719894432205BiotequeBioteque Taiwan Ltd.DT-A/S2024-03-29
04719894432212BiotequeBioteque Taiwan Ltd.DT-A/M2024-03-29
04719894432229BiotequeBioteque Taiwan Ltd.DT-A/L2024-03-29
04719894432236BiotequeBioteque Taiwan Ltd.DT-A/XL2024-04-08
04719894432243BiotequeBioteque Taiwan Ltd.DT-A2024-04-08
04719894432250BiotequeBioteque Taiwan Ltd.DT-B/S2024-04-08
04719894432267BiotequeBioteque Taiwan Ltd.DT-B/M2024-04-08
04719894432274BiotequeBioteque Taiwan Ltd.DT-B/L2024-04-08
04719894432281BiotequeBioteque Taiwan Ltd.DT-B/XL2024-04-08
04719894432298BiotequeBioteque Taiwan Ltd.DT-B2024-04-08
04719894432304BiotequeBioteque Taiwan Ltd.DT-C2024-04-08
00384702100016AmielleOWEN MUMFORD USA INCORPORATEDSM 21002016-09-19
00384703100015Amielle RestoreOWEN MUMFORD USA INCORPORATEDSM 31002022-09-15
00840306826535Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.260-6112024-05-09
00840306826542Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.260-6122024-05-09
00840343713744GEN2SURGIX MEDICAL LLCG2OB15352023-01-09
00840343725426GEN2SURGIX MEDICAL LLCG2OB16292025-01-16
00840343725433GEN2SURGIX MEDICAL LLCG2OB16302025-01-16
00840343725440GEN2SURGIX MEDICAL LLCG2OB16312025-01-16
00840343725457GEN2SURGIX MEDICAL LLCG2OB16322025-01-16
00840343725464GEN2SURGIX MEDICAL LLCG2OB16332025-01-16
00840343725471GEN2SURGIX MEDICAL LLCG2OB16342025-01-16
00840343725488GEN2SURGIX MEDICAL LLCG2OB16352025-01-16
00840343725495GEN2SURGIX MEDICAL LLCG2OB16362025-01-16
00840343725501GEN2SURGIX MEDICAL LLCG2OB16372025-01-16
00840343725518GEN2SURGIX MEDICAL LLCG2OB16382025-01-16
00850005838029Intimate RosePLUS EV HOLDINGS INC.IR-0142024-12-10
00850005838036Intimate RosePLUS EV HOLDINGS INC.IR-0152024-12-10
00850005838043Intimate RosePLUS EV HOLDINGS INC.IR-0162024-12-10
00850005838050Intimate RosePLUS EV HOLDINGS INC.IR-017-12024-12-10
00850005838067Intimate RosePLUS EV HOLDINGS INC.IR-017-22024-12-10
00850005838074Intimate RosePLUS EV HOLDINGS INC.IR-017-32024-12-10
00850005838081Intimate RosePLUS EV HOLDINGS INC.IR-017-42024-12-10
00850005838098Intimate RosePLUS EV HOLDINGS INC.IR-017-52024-12-10
00850005838104Intimate RosePLUS EV HOLDINGS INC.IR-017-62024-12-10
00850005838111Intimate RosePLUS EV HOLDINGS INC.IR-017-72024-12-10
00850005838128Intimate RosePLUS EV HOLDINGS INC.IR-017-82024-12-10
14026704791672PILLINGTELEFLEX INCORPORATEDIPN0176392022-12-08
14026704791689PILLINGTELEFLEX INCORPORATEDIPN0176402022-12-08
14026704791719PILLINGTELEFLEX INCORPORATEDIPN0176432022-12-08
14026704791726PILLINGTELEFLEX INCORPORATEDIPN0176442022-12-08
14026704791733PILLINGTELEFLEX INCORPORATEDIPN0176452022-12-08
14026704791740PILLINGTELEFLEX INCORPORATEDIPN0176462022-12-08
14026704791771PILLINGTELEFLEX INCORPORATEDIPN0176492022-12-08
14026704791788PILLINGTELEFLEX INCORPORATEDIPN0176502022-12-08
54026704791748PILLINGTELEFLEX INCORPORATEDIPN0176462022-12-08
54026704791786PILLINGTELEFLEX INCORPORATEDIPN0176502022-12-08
00198506088230ELMED INCORPORATEDELMED INCORPORATEDSTE71420192026-01-27
00198506088247ELMED INCORPORATEDELMED INCORPORATEDSTE71420212026-01-27
00198506088254ELMED INCORPORATEDELMED INCORPORATEDSTE71420232026-01-27
00198506088261ELMED INCORPORATEDELMED INCORPORATEDSTE71420252026-01-27
14026704791696PILLINGTELEFLEX INCORPORATEDIPN0176412022-12-08
14026704791702PILLINGTELEFLEX INCORPORATEDIPN0176422022-12-08
14026704791757PILLINGTELEFLEX INCORPORATEDIPN0176472022-12-08
14026704791764PILLINGTELEFLEX INCORPORATEDIPN0176482022-12-08
00198506087981ELMED INCORPORATEDELMED INCORPORATED71415-012026-01-22
00198506087998ELMED INCORPORATEDELMED INCORPORATED71415-022026-01-22
00198506088001ELMED INCORPORATEDELMED INCORPORATED71415-032026-01-22
00198506088018ELMED INCORPORATEDELMED INCORPORATED71415-042026-01-22
00198506088025ELMED INCORPORATEDELMED INCORPORATED71415-052026-01-22
00198506088032ELMED INCORPORATEDELMED INCORPORATED71415-062026-01-22
00198506088049ELMED INCORPORATEDELMED INCORPORATED71415-072026-01-22
00198506042157ELMED INCORPORATEDELMED INCORPORATEDST325004I2025-09-05
00198506000843ELMED INCORPORATEDELMED INCORPORATEDST3230122025-07-31
00810142352307Bioteque America, Inc.Bioteque America, Inc.DT-B2025-05-30
00810142352215Bioteque America, Inc.Bioteque America, Inc.DT-A/S2025-05-29
00810142352222Bioteque America, Inc.Bioteque America, Inc.DT-A/M2025-05-29
00810142352239Bioteque America, Inc.Bioteque America, Inc.DT-A/L2025-05-29
00810142352246Bioteque America, Inc.Bioteque America, Inc.DT-A/XL2025-05-29
00810142352260Bioteque America, Inc.Bioteque America, Inc.DT-B/S2025-05-29
00810142352277Bioteque America, Inc.Bioteque America, Inc.DT-B/M2025-05-29
00810142352284Bioteque America, Inc.Bioteque America, Inc.DT-B/L2025-05-29
00810142352291Bioteque America, Inc.Bioteque America, Inc.DT-B/XL2025-05-29
00810142352314Bioteque America, Inc.Bioteque America, Inc.DT-C2025-05-12
00810142352253Bioteque America, Inc.Bioteque America, Inc.DT-A2025-05-08
00198506000690ELMED INCORPORATEDELMED INCORPORATEDST3223222025-04-30
00198506000744ELMED INCORPORATEDELMED INCORPORATEDST3226022025-04-30
00198506000751ELMED INCORPORATEDELMED INCORPORATEDST3226042025-04-30
00198506000768ELMED INCORPORATEDELMED INCORPORATEDST3226062025-04-30
00198506000775ELMED INCORPORATEDELMED INCORPORATEDST3226082025-04-30