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Fukuda Denshi USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
68
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0661-2016Class IIFukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8December 21, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K173226CardiMax ElectrocardiographApril 16, 2018
K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorMarch 16, 2015
K134046FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITORFebruary 12, 2015
K112521FUKUDA DENSHI VASERA MODEL VS-1500December 21, 2011
K103134FUKUDA DENSHIMarch 11, 2011
K083697FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210MMarch 19, 2009
K082656MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNITSeptember 30, 2008
K081891FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITORAugust 29, 2008
K050363FUKUDA DENSHI MODEL UF-850XTDFebruary 17, 2005
K033711FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEMJune 3, 2004
K040246FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITORMay 26, 2004
K033209FUKUDA DENSHI MODEL FF SONIC UF-750XTOctober 31, 2003
K032290FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOROctober 10, 2003
K020084FUKUDA DENSHI DYNASCOPE MODEL DS-5700February 6, 2002
K013273FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULEDecember 20, 2001
K000746FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NXApril 7, 2000
K990401FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLEROctober 15, 1999
K981066FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPHAugust 31, 1998
K980728FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEMJune 19, 1998
K980979FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULEJune 12, 1998