Fukuda Denshi USA, Inc. - FDA 510(k) Cleared Devices
68
Total
68
Cleared
0
Denied
50 devices
Cleared
Aug 23, 1990
FUKUDA DENSHI MODEL FX-3101
Cardiovascular
122d
Cleared
Jul 17, 1990
FUKUDA DENSHI MODEL HJ-310
Cardiovascular
82d
Cleared
Feb 01, 1990
FUKUDA DENSHI MODEL DS-3300 ETR
Cardiovascular
43d
Cleared
Jan 08, 1990
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
Cardiovascular
168d
Cleared
Oct 02, 1989
FUKUDA DENSHI MODEL FCP-2201
Cardiovascular
168d
Cleared
Oct 02, 1989
MODEL DS-504 DYNASCOPE PATIENT MONITOR
Cardiovascular
153d
Cleared
Jan 12, 1989
FUKUDA DENSHI MODEL FX-1201
Cardiovascular
42d
Cleared
Mar 22, 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
Cardiovascular
104d
Cleared
Dec 18, 1987
FUKUDA DENSHI MODEL FCP-231
Cardiovascular
29d
Cleared
Mar 24, 1987
FUKUDA DENSHI MODEL FCP-15
Cardiovascular
8d
Cleared
Jan 06, 1987
MODIFICATION TO DYNASCOPE SERIES MONITORS
Cardiovascular
90d
Cleared
Aug 25, 1986
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
Cardiovascular
124d
Cleared
May 02, 1986
SCM-400 HOLTER SYSTEM
Cardiovascular
51d
Cleared
Feb 12, 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
Cardiovascular
51d
Cleared
Nov 14, 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
Cardiovascular
94d
Cleared
Oct 11, 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
Cardiovascular
144d
Cleared
Sep 19, 1985
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL
Cardiovascular
100d
Cleared
Jun 21, 1985
FUKUDA DENSHI EH-11
Cardiovascular
574d
Cleared
Apr 19, 1985
FC-700 DEFIBRILLATOR
Cardiovascular
63d
Cleared
Apr 10, 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
Cardiovascular
37d
Cleared
Feb 01, 1985
ARRHYTHMIA SYSTEM AC-11
Cardiovascular
325d
Cleared
Dec 04, 1984
DYNASCOPE MONITOR DS-800
Cardiovascular
35d
Cleared
Oct 19, 1984
THERMAL GRAYSCALE RF-100
Cardiovascular
18d
Cleared
Aug 22, 1984
DYNASCOPE SERIES
Cardiovascular
229d
Cleared
Jan 03, 1984
ELECTROCARDIOGRAPH MACHINES, W/ANALYZ
Cardiovascular
190d