Medical Device Manufacturer · US , Dyersville , IA

Tomy International, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2026

Recent clearances: MODO DUO Electric Pump (B11621, B11673)

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Denied

Tomy International, Inc. has 1 FDA 510(k) cleared medical devices. Based in Dyersville, US.

Latest FDA clearance: Oct 2026. Active since 2026. Primary specialty: Obstetrics & Gynecology.

Browse the FDA 510(k) cleared devices submitted by Tomy International, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Guangzhou GLOMED Biological Technology Co., Ltd. as regulatory consultant.

FDA 510(k) Regulatory Record - Tomy International, Inc.

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