Fukuda Denshi USA, Inc.

• DSI — Cardiovascular19 devices
• MHX — Cardiovascular8 devices
• DPS — Cardiovascular7 devices
• BZG — Anesthesiology4 devices
• DRT — Cardiovascular4 devices
• IYO — Radiology4 devices
• LOS — Unknown4 devices
• DQA — Cardiovascular3 devices
• DXN — Cardiovascular3 devices
• IYN — Radiology3 devices

• Z-0661-2016 — Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.Class II·Terminated·2015-12-21

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K173226 — CardiMax ElectrocardiographCode DPS·2018-04-16
• K150030 — Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorCode MHX·2015-03-16
• K134046 — FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITORCode MHX·2015-02-12
• K112521 — FUKUDA DENSHI VASERA MODEL VS-1500Code DXN·2011-12-21
• K103134 — FUKUDA DENSHICode MHX·2011-03-11
• K083697 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210MCode MHX·2009-03-19
• K082656 — MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNITCode IYN·2008-09-30
• K081891 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITORCode MHX·2008-08-29
• K050363 — FUKUDA DENSHI MODEL UF-850XTDCode IYN·2005-02-17
• K033711 — FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEMCode MHX·2004-06-03
• K040246 — FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITORCode MHX·2004-05-26
• K033209 — FUKUDA DENSHI MODEL FF SONIC UF-750XTCode IYN·2003-10-31
• K032290 — FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITORCode MHX·2003-10-10
• K020084 — FUKUDA DENSHI DYNASCOPE MODEL DS-5700Code DSI·2002-02-06
• K013273 — FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULECode DQA·2001-12-20
• K000746 — FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NXCode DSI·2000-04-07
• K990401 — FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLERCode IYO·1999-10-15
• K981066 — FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPHCode LOS·1998-08-31
• K980728 — FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEMCode DSI·1998-06-19
• K980979 — FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULECode CCK·1998-06-12
• K981404 — FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500Code IYO·1998-05-20
• K971440 — FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPHCode LOS·1997-12-02
• K971131 — FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITORCode DSI·1997-10-03
• K970585 — FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITORCode DSI·1997-09-09
• K964187 — FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITORCode DSI·1997-05-01
• K963057 — FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTERCode DSI·1997-03-21
• K955543 — ULTRASOUND SYSTEM MODEL UF-3500Code IYO·1997-02-11
• K955416 — CARDIMAX MODEL FX-2111Code DPS·1996-07-15
• K950044 — FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULECode CCK·1995-09-15
• K944262 — ECG MONITORCode DRT·1995-05-12
• K945464 — FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULECode DQA·1995-02-01
• K921454 — FUKUDA DENSHI MODEL HG-301Code DQA·1994-04-01
• K922208 — FUKUDA DENSHI MODEL UF-4500Code IYO·1993-08-30
• K922428 — FUKUDA DENSHI MODEL SPIROSIFT SP-5000Code BZG·1993-01-15
• K915879 — HL-300 RECEIVER MODULECode DPS·1992-01-27
• K913811 — FUKUDA DENSHI MODEL FCP-4101Code LOS·1991-12-09
• K904200 — SPIROSIFT 500ACode BZG·1991-05-22
• K903514 — FUKUDA DENSHI MODEL LX-3100Code DSI·1991-01-30
• K903704 — FUKUDA DENSHI MODEL FCP-2201 MODIFICATIONCode DSI·1990-09-07
• K901817 — FUKUDA DENSHI MODEL FX-3101Code DPS·1990-08-23
• K901889 — FUKUDA DENSHI MODEL HJ-310Code DXN·1990-07-17
• K900391 — FUKUDA DENSHI MODEL SPIROSIFT 3000Code BZG·1990-04-10
• K897063 — FUKUDA DENSHI MODEL DS-3300 ETRCode DSI·1990-02-01
• K897094 — MODIFIED SPIROSCAN 1000Code BZG·1990-01-12
• K894628 — MODEL DS-3300 DYNASCOPE PATIENT MONITORCode DSI·1990-01-08
• K892796 — FUKUDA DENSHI MODEL FCP-2201Code LOS·1989-10-02
• K893405 — MODEL DS-504 DYNASCOPE PATIENT MONITORCode DRT·1989-10-02
• K884992 — FUKUDA DENSHI MODEL FX-1201Code DPS·1989-01-12
• K875057 — FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITORCode DPS·1988-03-22
• K874768 — FUKUDA DENSHI MODEL FCP-231Code DSI·1987-12-18
• K871385 — MODEL U-1000 WITH GESTATIONAL AGE CALCULATIONCode HGM·1987-05-26
• K871025 — FUKUDA DENSHI MODEL FCP-15Code DSI·1987-03-24
• K863914 — MODIFICATION TO DYNASCOPE SERIES MONITORSCode DPS·1987-01-06
• K861504 — MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITORCode DXN·1986-08-25
• K860950 — SCM-400 HOLTER SYSTEMCode DSI·1986-05-02
• K855094 — FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATACode DSI·1986-02-12
• K853352 — FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITORCode DSI·1985-11-14
• K853213 — FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MONCode DSI·1985-10-11
• K851902 — MODEL U-1000 ULTRASONIC SCANNERCode HEM·1985-09-27
• K852487 — FUKUDA DENSHI MODEL AU-5001-5003 THERMALCode DSF·1985-09-19
• K834059 — FUKUDA DENSHI EH-11Code DXG·1985-06-21
• K850618 — FC-700 DEFIBRILLATORCode LDD·1985-04-19
• K850897 — FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIESCode DSI·1985-04-10
• K841084 — ARRHYTHMIA SYSTEM AC-11Code DSI·1985-02-01
• K844348 — DYNASCOPE MONITOR DS-800Code DRT·1984-12-04
• K843836 — THERMAL GRAYSCALE RF-100Code DSF·1984-10-19
• K840055 — DYNASCOPE SERIESCode DRT·1984-08-22
• K832092 — ELECTROCARDIOGRAPH MACHINES, W/ANALYZ·1984-01-03