Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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