Fukuda Denshi Usa Inc

FDA Filings

This page includes the latest FDA filings for Fukuda Denshi Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Fukuda Denshi Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Doug Blakely
• Doug W Blakely
• Fukuda Denshi Fine Tech Sendai Co. Ltd.

FDA Registration(s)

• Registration Number: 3031158
• FEI Number: 3000215024
• Name: FUKUDA DENSHI USA, INC.
• Owner & Operator: FUKUDA DENSHI CO., LTD.
• Contact Address: 3-39-4, HONGO, BUNKYO-KO --; TOKYO JP-NOTA 113 JP
• Official Correspondent:
  • Doug W Blakely
  • 81-3-56841455-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 17725 N.E. 65TH ST., BLDG. C ; REDMOND, WA 98052 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00860002604404 FUKUDA DENSHI USA, INC.	Fukuda Vital Signs Monitor	2021-11-10
PMN K173226 | DPS FUKUDA DENSHI USA, INC. [FUKUDA DENSHI CO., LTD.]	CardiMax Model FX-8322 Electrocardiograph	2018-04-30
PMN K173226 Fukuda Denshi USA, Inc.	CardiMax Electrocardiograph	2018-04-16
PMN K150030 | MHX FUKUDA DENSHI USA, INC. [FUKUDA DENSHI CO., LTD.]	DS-8200/DS-8400-8007/DS-8500	2015-03-26
PMN K134046 | MHX FUKUDA DENSHI USA, INC. [FUKUDA DENSHI CO., LTD.]	DS-8100	2015-03-26
PMN K150030 Fukuda Denshi USA, Inc.	Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor	2015-03-16
PMN K134046 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR	2015-02-12
PMN K112521 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI VASERA MODEL VS-1500	2011-12-21
PMN K103134 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI	2011-03-11
PMN K083697 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M	2009-03-19
PMN K082656 FUKUDA DENSHI USA, INC.	MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT	2008-09-30
PMN K081891 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR	2008-08-29
PMN K050363 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL UF-850XTD	2005-02-17
PMN K033711 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM	2004-06-03
PMN K040246 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR	2004-05-26
PMN K033209 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL FF SONIC UF-750XT	2003-10-31
PMN K032290 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR	2003-10-10
PMN K020084 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE MODEL DS-5700	2002-02-06
PMN K013273 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE	2001-12-20
PMN K000746 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX	2000-04-07
PMN K990401 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER	1999-10-15
PMN K981066 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH	1998-08-31
PMN K980728 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM	1998-06-19
PMN K980979 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE	1998-06-12
PMN K981404 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500	1998-05-20
PMN K971440 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH	1997-12-02
PMN K971131 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR	1997-10-03
PMN K970585 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR	1997-09-09
PMN K964187 FUKUDA DENSHI USA, INC.	FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR	1997-05-01
PMN K963057 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER	1997-03-21
PMN K955543 FUKUDA DENSHI USA, INC.	ULTRASOUND SYSTEM MODEL UF-3500	1997-02-11
PMN K955416 FUKUDA DENSHI USA, INC.	CARDIMAX MODEL FX-2111	1996-07-15
PMN K950044 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE	1995-09-15
PMN K944262 FUKUDA DENSHI USA, INC.	ECG MONITOR	1995-05-12
PMN K945464 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE	1995-02-01
PMN K921454 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL HG-301	1994-04-01
PMN K922208 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL UF-4500	1993-08-30
PMN K922428 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL SPIROSIFT SP-5000	1993-01-15
PMN K915879 FUKUDA DENSHI USA, INC.	HL-300 RECEIVER MODULE	1992-01-27
PMN K913811 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL FCP-4101	1991-12-09
PMN K904200 FUKUDA DENSHI USA, INC.	SPIROSIFT 500A	1991-05-22
PMN K903514 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL LX-3100	1991-01-30
PMN K903704 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL FCP-2201 MODIFICATION	1990-09-07
PMN K901817 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL FX-3101	1990-08-23
PMN K901889 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL HJ-310	1990-07-17
PMN K900391 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL SPIROSIFT 3000	1990-04-10
PMN K897063 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL DS-3300 ETR	1990-02-01
PMN K897094 FUKUDA DENSHI USA, INC.	MODIFIED SPIROSCAN 1000	1990-01-12
PMN K894628 FUKUDA DENSHI USA, INC.	MODEL DS-3300 DYNASCOPE PATIENT MONITOR	1990-01-08
PMN K893405 FUKUDA DENSHI USA, INC.	MODEL DS-504 DYNASCOPE PATIENT MONITOR	1989-10-02
PMN K892796 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL FCP-2201	1989-10-02
PMN K884992 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL FX-1201	1989-01-12
PMN K875057 FUKUDA DENSHI USA, INC.	FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR	1988-03-22
PMN K874768 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL FCP-231	1987-12-18
PMN K871385 FUKUDA DENSHI USA, INC.	MODEL U-1000 WITH GESTATIONAL AGE CALCULATION	1987-05-26
PMN K871025 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL FCP-15	1987-03-24
PMN K863914 FUKUDA DENSHI USA, INC.	MODIFICATION TO DYNASCOPE SERIES MONITORS	1987-01-06
PMN K861504 FUKUDA DENSHI USA, INC.	MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR	1986-08-25
PMN K860950 FUKUDA DENSHI USA, INC.	SCM-400 HOLTER SYSTEM	1986-05-02
PMN K855094 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA	1986-02-12
PMN K853352 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR	1985-11-14
PMN K853213 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON	1985-10-11
PMN K851902 FUKUDA DENSHI USA, INC.	MODEL U-1000 ULTRASONIC SCANNER	1985-09-27
PMN K852487 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI MODEL AU-5001-5003 THERMAL	1985-09-19
PMN K834059 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI EH-11	1985-06-21
PMN K850618 FUKUDA DENSHI USA, INC.	FC-700 DEFIBRILLATOR	1985-04-19
PMN K850897 FUKUDA DENSHI USA, INC.	FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES	1985-04-10
PMN K841084 FUKUDA DENSHI USA, INC.	ARRHYTHMIA SYSTEM AC-11	1985-02-01
PMN K844348 FUKUDA DENSHI USA, INC.	DYNASCOPE MONITOR DS-800	1984-12-04
PMN K843836 FUKUDA DENSHI USA, INC.	THERMAL GRAYSCALE RF-100	1984-10-19
PMN K840055 FUKUDA DENSHI USA, INC.	DYNASCOPE SERIES	1984-08-22
PMN K832092 FUKUDA DENSHI USA, INC.	ELECTROCARDIOGRAPH MACHINES, W/ANALYZ	1984-01-03

Related Finance Registrations

NCAGE Code	6WJF0	FUKUDA DENSHI USA, INC.
CAGE Code	6WJF0	FUKUDA DENSHI USA, INC.
S.A.M. Registration	6WJF0 [199040556]	FUKUDA DENSHI USA, INC.
DUNS	199040556	Fukuda Denshi Usa, Inc.