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."
49–68 of 68
Search insights Median review: 105d Cleared: 100% Top manufacturer: Fukuda Denshi USA, Inc. Lead specialty: Cardiovascular
Cleared Mar 22, 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 104d
Cleared Dec 18, 1987
FUKUDA DENSHI MODEL FCP-231
K874768 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 29d
Cleared May 26, 1987
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION
K871385 · HGM
Fukuda Denshi USA, Inc.
Obstetrics & Gynecology · 49d
Cleared Mar 24, 1987
FUKUDA DENSHI MODEL FCP-15
K871025 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 8d
Cleared Jan 06, 1987
MODIFICATION TO DYNASCOPE SERIES MONITORS
K863914 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 90d
Cleared Aug 25, 1986
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
K861504 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 124d
Cleared May 02, 1986
SCM-400 HOLTER SYSTEM
K860950 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared Feb 12, 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared Nov 14, 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Oct 11, 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 144d
Cleared Sep 27, 1985
MODEL U-1000 ULTRASONIC SCANNER
K851902 · HEM
Fukuda Denshi USA, Inc.
Obstetrics & Gynecology · 150d
Cleared Sep 19, 1985
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL
K852487 · DSF
Fukuda Denshi USA, Inc.
Cardiovascular · 100d
Cleared Jun 21, 1985
FUKUDA DENSHI EH-11
K834059 · DXG
Fukuda Denshi USA, Inc.
Cardiovascular · 574d
Cleared Apr 19, 1985
FC-700 DEFIBRILLATOR
K850618 · LDD
Fukuda Denshi USA, Inc.
Cardiovascular · 63d
Cleared Apr 10, 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 37d
Cleared Feb 01, 1985
ARRHYTHMIA SYSTEM AC-11
K841084 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 325d
Cleared Dec 04, 1984
DYNASCOPE MONITOR DS-800
K844348 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 35d
Cleared Oct 19, 1984
THERMAL GRAYSCALE RF-100
K843836 · DSF
Fukuda Denshi USA, Inc.
Cardiovascular · 18d
Cleared Aug 22, 1984
DYNASCOPE SERIES
K840055 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 229d
Cleared Jan 03, 1984
ELECTROCARDIOGRAPH MACHINES, W/ANALYZ
K832092
Fukuda Denshi USA, Inc.
Cardiovascular · 190d