Medical Device Manufacturer · US , Mchenry , IL

Fukuda Denshi USA, Inc. - FDA 510(k) Cleared Devices

68 submissions · 68 cleared · Since 1984

Recent clearances: CardiMax Electrocardiograph, Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor, FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR

68

Total

68

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fukuda Denshi USA, Inc. Radiology ✕

7 devices

1-7 of 7

Cleared Sep 30, 2008

MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT

Radiology · 18d

Cleared Feb 17, 2005

FUKUDA DENSHI MODEL UF-850XTD

Radiology · 3d

Cleared Oct 31, 2003

FUKUDA DENSHI MODEL FF SONIC UF-750XT

Radiology · 28d

Cleared Oct 15, 1999

FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM...

Radiology · 248d

Cleared May 20, 1998

FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500

Radiology · 33d

Cleared Feb 11, 1997

ULTRASOUND SYSTEM MODEL UF-3500

Radiology · 434d

Cleared Aug 30, 1993

FUKUDA DENSHI MODEL UF-4500

Radiology · 475d