FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

68 results for "Fukuda Denshi USA, Inc."
1–24 of 68
Search insights Median review: 105d Cleared: 100% Top manufacturer: Fukuda Denshi USA, Inc. Lead specialty: Cardiovascular
Cleared Apr 16, 2018
CardiMax Electrocardiograph
K173226 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 195d
Cleared Mar 16, 2015
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
K150030 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 67d
Cleared Feb 12, 2015
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
K134046 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 408d
Cleared Dec 21, 2011
FUKUDA DENSHI VASERA MODEL VS-1500
K112521 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 112d
Cleared Mar 11, 2011
FUKUDA DENSHI
K103134 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 137d
Cleared Mar 19, 2009
FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL...
K083697 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Sep 30, 2008
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
K082656 · IYN
Fukuda Denshi USA, Inc.
Radiology · 18d
Cleared Aug 29, 2008
FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR
K081891 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 58d
Cleared Feb 17, 2005
FUKUDA DENSHI MODEL UF-850XTD
K050363 · IYN
Fukuda Denshi USA, Inc.
Radiology · 3d
Cleared Jun 03, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
K033711 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared May 26, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR
K040246 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 113d
Cleared Oct 31, 2003
FUKUDA DENSHI MODEL FF SONIC UF-750XT
K033209 · IYN
Fukuda Denshi USA, Inc.
Radiology · 28d
Cleared Oct 10, 2003
FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR
K032290 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 78d
Cleared Feb 06, 2002
FUKUDA DENSHI DYNASCOPE MODEL DS-5700
K020084 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 27d
Cleared Dec 20, 2001
FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
K013273 · DQA
Fukuda Denshi USA, Inc.
Anesthesiology · 80d
Cleared Apr 07, 2000
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
K000746 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 30d
Cleared Oct 15, 1999
FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM...
K990401 · IYO
Fukuda Denshi USA, Inc.
Radiology · 248d
Cleared Aug 31, 1998
FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH
K981066 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 160d
Cleared Jun 19, 1998
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM
K980728 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 114d
Cleared Jun 12, 1998
FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE
K980979 · CCK
Fukuda Denshi USA, Inc.
Anesthesiology · 87d
Cleared May 20, 1998
FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500
K981404 · IYO
Fukuda Denshi USA, Inc.
Radiology · 33d
Cleared Dec 02, 1997
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K971440 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 228d
Cleared Oct 03, 1997
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
K971131 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Sep 09, 1997
FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
K970585 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 207d