Fukuda Denshi USA, Inc. - FDA 510(k) Cleared Devices
68
Total
68
Cleared
0
Denied
68 devices
Cleared
Mar 21, 1997
FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
Cardiovascular
227d
Cleared
Feb 11, 1997
ULTRASOUND SYSTEM MODEL UF-3500
Radiology
434d
Cleared
Jul 15, 1996
CARDIMAX MODEL FX-2111
Cardiovascular
231d
Cleared
Sep 15, 1995
FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE
Anesthesiology
253d
Cleared
May 12, 1995
ECG MONITOR
Cardiovascular
255d
Cleared
Feb 01, 1995
FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE
Anesthesiology
86d
Cleared
Apr 01, 1994
FUKUDA DENSHI MODEL HG-301
Anesthesiology
736d
Cleared
Aug 30, 1993
FUKUDA DENSHI MODEL UF-4500
Radiology
475d
Cleared
Jan 15, 1993
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
Anesthesiology
238d
Cleared
Jan 27, 1992
HL-300 RECEIVER MODULE
Cardiovascular
28d
Cleared
Dec 09, 1991
FUKUDA DENSHI MODEL FCP-4101
Cardiovascular
105d
Cleared
May 22, 1991
SPIROSIFT 500A
Anesthesiology
252d
Cleared
Jan 30, 1991
FUKUDA DENSHI MODEL LX-3100
Cardiovascular
180d
Cleared
Sep 07, 1990
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
Cardiovascular
87d
Cleared
Aug 23, 1990
FUKUDA DENSHI MODEL FX-3101
Cardiovascular
122d
Cleared
Jul 17, 1990
FUKUDA DENSHI MODEL HJ-310
Cardiovascular
82d
Cleared
Apr 10, 1990
FUKUDA DENSHI MODEL SPIROSIFT 3000
Anesthesiology
74d
Cleared
Feb 01, 1990
FUKUDA DENSHI MODEL DS-3300 ETR
Cardiovascular
43d
Cleared
Jan 12, 1990
MODIFIED SPIROSCAN 1000
Anesthesiology
23d
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