Company ยท US
Fukuda Denshi USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2018. Name variants (Inc, Corp, punctuation) are merged.
70510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 19 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 10 |
| DPS | Electrocardiograph | 7 |
| BZG | Spirometer, Diagnostic | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 |
| LOS | 4 | |
| DQA | Oximeter | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| DSF | Recorder, Paper Chart | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 |
| HGM | System, Monitoring, Perinatal | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 16, 2018 | K173226 | CardiMax Electrocardiograph Fukuda Denshi USA, Inc. | DPS |
| Mar 16, 2015 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor Fukuda Denshi USA, Inc. | MHX |
| Feb 12, 2015 | K134046 | FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR Fukuda Denshi USA, Inc. | MHX |
| Dec 21, 2011 | K112521 | FUKUDA DENSHI VASERA MODEL VS-1500 Fukuda Denshi USA, Inc. | DXN |
| Apr 8, 2011 | K110920 | UF-760AG Fukuda Denshi Co., Ltd. | ITX |
| Mar 11, 2011 | K103134 | FUKUDA DENSHI Fukuda Denshi USA, Inc. | MHX |
| Mar 19, 2009 | K083697 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M Fukuda Denshi USA, Inc. | MHX |
| Sep 30, 2008 | K082656 | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT Fukuda Denshi USA, Inc. | IYN |
| Sep 9, 2008 | K081919 | UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM Fukuda Denshi Co., Ltd. | ITX |
| Aug 29, 2008 | K081891 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR Fukuda Denshi USA, Inc. | MHX |
| Feb 17, 2005 | K050363 | FUKUDA DENSHI MODEL UF-850XTD Fukuda Denshi USA, Inc. | IYN |
| Jun 3, 2004 | K033711 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM Fukuda Denshi USA, Inc. | MHX |
| May 26, 2004 | K040246 | FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR Fukuda Denshi USA, Inc. | MHX |
| Oct 31, 2003 | K033209 | FUKUDA DENSHI MODEL FF SONIC UF-750XT Fukuda Denshi USA, Inc. | IYN |
| Oct 10, 2003 | K032290 | FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR Fukuda Denshi USA, Inc. | MHX |
| Feb 6, 2002 | K020084 | FUKUDA DENSHI DYNASCOPE MODEL DS-5700 Fukuda Denshi USA, Inc. | DSI |
| Dec 20, 2001 | K013273 | FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE Fukuda Denshi USA, Inc. | DQA |
| Apr 7, 2000 | K000746 | FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX Fukuda Denshi USA, Inc. | DSI |
| Oct 15, 1999 | K990401 | FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER Fukuda Denshi USA, Inc. | IYO |
| Aug 31, 1998 | K981066 | FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH Fukuda Denshi USA, Inc. | LOS |
| Jun 19, 1998 | K980728 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM Fukuda Denshi USA, Inc. | DSI |
| Jun 12, 1998 | K980979 | FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE Fukuda Denshi USA, Inc. | CCK |
| May 20, 1998 | K981404 | FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 Fukuda Denshi USA, Inc. | IYO |
| Dec 2, 1997 | K971440 | FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH Fukuda Denshi USA, Inc. | LOS |
| Oct 3, 1997 | K971131 | FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR Fukuda Denshi USA, Inc. | DSI |
| Sep 9, 1997 | K970585 | FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR Fukuda Denshi USA, Inc. | DSI |
| May 1, 1997 | K964187 | FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR Fukuda Denshi USA, Inc. | DSI |
| Mar 21, 1997 | K963057 | FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER Fukuda Denshi USA, Inc. | DSI |
| Feb 11, 1997 | K955543 | ULTRASOUND SYSTEM MODEL UF-3500 Fukuda Denshi USA, Inc. | IYO |
| Jul 15, 1996 | K955416 | CARDIMAX MODEL FX-2111 Fukuda Denshi USA, Inc. | DPS |
| Sep 15, 1995 | K950044 | FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE Fukuda Denshi USA, Inc. | CCK |
| May 12, 1995 | K944262 | ECG MONITOR Fukuda Denshi USA, Inc. | DRT |
| Feb 1, 1995 | K945464 | FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE Fukuda Denshi USA, Inc. | DQA |
| Apr 1, 1994 | K921454 | FUKUDA DENSHI MODEL HG-301 Fukuda Denshi USA, Inc. | DQA |
| Aug 30, 1993 | K922208 | FUKUDA DENSHI MODEL UF-4500 Fukuda Denshi USA, Inc. | IYO |
| Jan 15, 1993 | K922428 | FUKUDA DENSHI MODEL SPIROSIFT SP-5000 Fukuda Denshi USA, Inc. | BZG |
| Jan 27, 1992 | K915879 | HL-300 RECEIVER MODULE Fukuda Denshi USA, Inc. | DPS |
| Dec 9, 1991 | K913811 | FUKUDA DENSHI MODEL FCP-4101 Fukuda Denshi USA, Inc. | LOS |
| May 22, 1991 | K904200 | SPIROSIFT 500A Fukuda Denshi USA, Inc. | BZG |
| Jan 30, 1991 | K903514 | FUKUDA DENSHI MODEL LX-3100 Fukuda Denshi USA, Inc. | DSI |
| Sep 7, 1990 | K903704 | FUKUDA DENSHI MODEL FCP-2201 MODIFICATION Fukuda Denshi USA, Inc. | DSI |
| Aug 23, 1990 | K901817 | FUKUDA DENSHI MODEL FX-3101 Fukuda Denshi USA, Inc. | DPS |
| Jul 17, 1990 | K901889 | FUKUDA DENSHI MODEL HJ-310 Fukuda Denshi USA, Inc. | DXN |
| Apr 10, 1990 | K900391 | FUKUDA DENSHI MODEL SPIROSIFT 3000 Fukuda Denshi USA, Inc. | BZG |
| Feb 1, 1990 | K897063 | FUKUDA DENSHI MODEL DS-3300 ETR Fukuda Denshi USA, Inc. | DSI |
| Jan 12, 1990 | K897094 | MODIFIED SPIROSCAN 1000 Fukuda Denshi USA, Inc. | BZG |
| Jan 8, 1990 | K894628 | MODEL DS-3300 DYNASCOPE PATIENT MONITOR Fukuda Denshi USA, Inc. | DSI |
| Oct 2, 1989 | K893405 | MODEL DS-504 DYNASCOPE PATIENT MONITOR Fukuda Denshi USA, Inc. | DRT |
| Oct 2, 1989 | K892796 | FUKUDA DENSHI MODEL FCP-2201 Fukuda Denshi USA, Inc. | LOS |
| Jan 12, 1989 | K884992 | FUKUDA DENSHI MODEL FX-1201 Fukuda Denshi USA, Inc. | DPS |
Newest 50 of 70.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2017 | Fukuda Denshi Co., Ltd. Fukuda Denshi patient monitor model DS-8100M and DS-8100N
Product Usage:
Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of Completed |
MHX | K134046 |
| Jan 16, 2016 | Fukuda Denshi USA, Inc. 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. Terminated |
MHX | K134046 |