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."
25–48 of 68
Search insights Median review: 105d Cleared: 100% Top manufacturer: Fukuda Denshi USA, Inc. Lead specialty: Cardiovascular
Cleared May 01, 1997
FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR
K964187 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 192d
Cleared Mar 21, 1997
FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
K963057 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 227d
Cleared Feb 11, 1997
ULTRASOUND SYSTEM MODEL UF-3500
K955543 · IYO
Fukuda Denshi USA, Inc.
Radiology · 434d
Cleared Jul 15, 1996
CARDIMAX MODEL FX-2111
K955416 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 231d
Cleared Sep 15, 1995
FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE
K950044 · CCK
Fukuda Denshi USA, Inc.
Anesthesiology · 253d
Cleared May 12, 1995
ECG MONITOR
K944262 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 255d
Cleared Feb 01, 1995
FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE
K945464 · DQA
Fukuda Denshi USA, Inc.
Anesthesiology · 86d
Cleared Apr 01, 1994
FUKUDA DENSHI MODEL HG-301
K921454 · DQA
Fukuda Denshi USA, Inc.
Anesthesiology · 736d
Cleared Aug 30, 1993
FUKUDA DENSHI MODEL UF-4500
K922208 · IYO
Fukuda Denshi USA, Inc.
Radiology · 475d
Cleared Jan 15, 1993
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K922428 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 238d
Cleared Jan 27, 1992
HL-300 RECEIVER MODULE
K915879 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 28d
Cleared Dec 09, 1991
FUKUDA DENSHI MODEL FCP-4101
K913811 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 105d
Cleared May 22, 1991
SPIROSIFT 500A
K904200 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 252d
Cleared Jan 30, 1991
FUKUDA DENSHI MODEL LX-3100
K903514 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 180d
Cleared Sep 07, 1990
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
K903704 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 87d
Cleared Aug 23, 1990
FUKUDA DENSHI MODEL FX-3101
K901817 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 122d
Cleared Jul 17, 1990
FUKUDA DENSHI MODEL HJ-310
K901889 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 82d
Cleared Apr 10, 1990
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 74d
Cleared Feb 01, 1990
FUKUDA DENSHI MODEL DS-3300 ETR
K897063 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 43d
Cleared Jan 12, 1990
MODIFIED SPIROSCAN 1000
K897094 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 23d
Cleared Jan 08, 1990
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
K894628 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 168d
Cleared Oct 02, 1989
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 153d
Cleared Oct 02, 1989
FUKUDA DENSHI MODEL FCP-2201
K892796 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 168d
Cleared Jan 12, 1989
FUKUDA DENSHI MODEL FX-1201
K884992 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 42d