Medical Device Manufacturer · US , Seattle , WA

Sime Health, Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1991

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sime Health, Ltd. Obstetrics & Gynecology ✕

5 devices

1-5 of 5

Cleared Jun 16, 1995

AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI

Obstetrics & Gynecology · 728d

Cleared Jul 07, 1994

SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)

Obstetrics & Gynecology · 384d

Cleared Jul 07, 1994

COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)

Obstetrics & Gynecology · 384d

Cleared Jul 07, 1994

UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI

Obstetrics & Gynecology · 384d

Cleared Jun 01, 1992

JIFFI CONDOM (RUBBER) CONTRACEPTIVE

Obstetrics & Gynecology · 280d