FDA Product Code
FDA Product Code DXG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1435
510(k) Clearances — 177 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | 2026-02-13 | Traditional | PDF ↗ |
| K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | 2025-09-26 | Traditional | PDF ↗ |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMS | Icu Medical | 2023-12-20 | Traditional | PDF ↗ |
| K212529 | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | 2021-11-23 | Special | PDF ↗ |
| K192169 | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | 2020-04-30 | Traditional | PDF ↗ |
| K193179 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019-12-17 | Special | PDF ↗ |
| K190955 | Hypotension Decision Assist | Directed Systems, Ltd. | 2019-11-27 | Traditional | PDF ↗ |
| K181372 | Argos | Retia Medical, LLC | 2018-12-13 | Traditional | PDF ↗ |
| K172259 | PulsioFlex Monitoring System | Pulsion Medical Systems SE | 2018-01-18 | Traditional | PDF ↗ |
| K163334 | LiDCOunity v2 Hemodynamic Monitor | Lidco, Ltd. | 2017-06-05 | Traditional | PDF ↗ |
| K152935 | LiDCOunity Monitor | Lidco, Ltd. | 2016-03-17 | Traditional | PDF ↗ |
| K134051 | TRANSONIC ELSA SYSTEM | Transonic Systems, Inc. | 2015-01-29 | Traditional | PDF ↗ |
| K134035 | TRANSONIC HCM 103 SYSTEM | Transonic Systems, Inc. | 2014-09-17 | Traditional | PDF ↗ |
| K140017 | TRANSONIC HCM 102 SYSTEM | Transonic Systems, Inc. | 2014-09-16 | Traditional | PDF ↗ |
| K132892 | TEBCO-W | Bomed, Inc. | 2014-08-01 | Traditional | PDF ↗ |
| K131588 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR | Edwards Lifesciences, LLC | 2014-05-22 | Traditional | PDF ↗ |
| K131892 | EV1000 CLINICAL PLATFORM | Edwards Lifesciences, LLC | 2014-05-22 | Traditional | PDF ↗ |
| K132528 | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | GE Healthcare Finland Oy | 2014-01-16 | Traditional | PDF ↗ |
| K122400 | CARDIOX FLOW DETECTION SYSTEM | Cardiox Corp. | 2013-11-05 | Traditional | PDF ↗ |
| K131048 | LIDCO CNAP MODULE | Lidco, Ltd. | 2013-08-28 | Traditional | PDF ↗ |
| K122247 | LIDCORAPID V2 MONITOR | Lidco, Ltd. | 2013-03-20 | Traditional | PDF ↗ |
| K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | Transonic Systems, Inc. | 2012-09-07 | Traditional | PDF ↗ |
| K122121 | PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE | Pulsion Medical Systems SE | 2012-08-02 | Special | PDF ↗ |
| K112448 | PULSIOFLEX | Pulsion Medical Systems, Inc. | 2011-09-22 | Special | PDF ↗ |
| K110597 | EV1000 CLINICAL PLATFORM | Edwards Lifesciences | 2011-06-14 | Traditional | PDF ↗ |
| K103094 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR | Edwards Lifesciences, LLC | 2011-05-17 | Traditional | PDF ↗ |
| K100709 | EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M | Edwards Lifesciences, LLC | 2010-12-07 | Traditional | PDF ↗ |
| K101487 | CHEETAH NICOM SYSTEM | Cheetah Medical, Inc. | 2010-07-02 | Abbreviated | PDF ↗ |
| K091786 | PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) | Pulsion Medical Systems AG | 2010-06-18 | Traditional | PDF ↗ |
| K092219 | NAVIGATOR CLINICAL GUIDENCE SYSTEM | Applied Physiology Pty , Ltd. | 2010-05-12 | Traditional | PDF ↗ |
| K082308 | MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR | Edwards Lifesciences, LLC | 2008-12-09 | Traditional | PDF ↗ |
| K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | Transonic Systems, Inc. | 2008-09-08 | Traditional | PDF ↗ |
| K081776 | CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM | Omega Critical Care Limited | 2008-07-22 | Special | PDF ↗ |
| K071631 | NICOM ELECTRODES | Cheetah Medical, Inc. | 2008-01-18 | Traditional | PDF ↗ |
| K073113 | INFINITY PICCO POD, MODEL MS16734 | Draeger Medical Systems, Inc. | 2008-01-03 | Traditional | PDF ↗ |
| K072735 | PULSION PICCO-2, MODEL 8500 | Pulsion Medical Systems AG | 2007-10-18 | Special | PDF ↗ |
| K062134 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR | Edwards Lifesciences, LLC | 2006-08-22 | Special | PDF ↗ |
| K060898 | PULSION PICCO PLUS, MODEL 8100 | Pulsion Medical Systems AG | 2006-07-25 | Traditional | PDF ↗ |
| K060660 | EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER | Edwards Lifesciences, LLC | 2006-04-25 | Traditional | PDF ↗ |
| K043103 | VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 | Edwards Lifesciences, LLC | 2004-12-09 | Special | PDF ↗ |
| K042144 | NICOM | Cheetah Medical, Inc. | 2004-11-12 | Traditional | PDF ↗ |
| K040287 | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR | Edwards Lifesciences, LLC | 2004-04-26 | Traditional | PDF ↗ |
| K032997 | MODIFICATION TO: HORIZON 9000WS | Mennen Medical , Ltd. | 2003-10-15 | Special | PDF ↗ |
| K023960 | LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 | Lidco, Ltd. | 2003-01-09 | Special | PDF ↗ |
| K021874 | ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 | Abbott Laboratories | 2002-07-12 | Traditional | PDF ↗ |
| K010049 | PULSECO HEMODYNAMIC MONITOR CM71 | Lidco, Ltd. | 2001-06-14 | Traditional | PDF ↗ |
| K000664 | VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS | Baxter Healthcare Corp | 2000-09-20 | Traditional | PDF ↗ |
| K001762 | PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM | Pulsion Medical Systems, Inc. | 2000-06-13 | Traditional | PDF ↗ |
| K991775 | MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS | Mennen Medical, Inc. | 1999-06-24 | Special | PDF ↗ |
| K962918 | LIDCO SYSTEM | Lidco, Ltd. | 1999-01-08 | Traditional | PDF ↗ |
| K970784 | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T) | Alexander Mfg. Co. | 1997-05-14 | Traditional | PDF ↗ |
| K961661 | OXIMETRIX 4 COMPUTER SYSTEM | Abbott Laboratories | 1997-03-04 | Traditional | PDF ↗ |
| K962128 | TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) | Hemo Sapiens, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K955417 | VITAL PAK | Vital Signs, Inc. | 1996-03-08 | Traditional | PDF ↗ |
| K946115 | EK-VIEW(TM) ECG MANAGEMENT SYSTEM | Apcot Medical Systems | 1995-03-01 | Traditional | PDF ↗ |
| K940415 | HORIZON 9000 WS | Mennen Medical, Inc. | 1995-01-06 | Traditional | PDF ↗ |
| K943256 | CARDIAC OUTPUT OPTION 39 | Medical Data Electronics | 1994-12-15 | Traditional | PDF ↗ |
| K932414 | CONTINUOUS CARDIAC OUTPUT SYSTEM | Abbott Laboratories | 1994-11-14 | Traditional | PDF ↗ |
| K922218 | IQ SYSTEM | Renaissance Technology, Inc. | 1992-12-08 | Traditional | PDF ↗ |
| K913358 | MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST | Ppg Industries, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K902628 | INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT | Biometric Research Institute, Inc. | 1991-02-25 | Traditional | PDF ↗ |
| K896930 | CARDIAC OUTPUT COMPUTER, MODEL COM-3 | Baxter Healthcare Corp | 1990-07-03 | Traditional | PDF ↗ |
| K901926 | SORBA MODEL CIC-1000 W/NEW ELECTRODES | Sorba Medical Systems, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K895017 | SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH | Sorba Medical Systems, Inc. | 1990-03-14 | Traditional | PDF ↗ |
| K897004 | NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM | Advanced Technology Laboratories, Inc. | 1990-03-13 | Traditional | PDF ↗ |
| K896528 | SFA MODULE | Life Sciences Manufacturing, Inc. | 1990-01-26 | Traditional | PDF ↗ |
| K894234 | SENSOCOR TM R-TEST 24OXL | Sensocor | 1989-08-03 | Traditional | PDF ↗ |
| K893392 | CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER | Baxter Healthcare Corp | 1989-06-20 | Traditional | PDF ↗ |
| K884122 | TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA | S & W Medico Teknik | 1989-04-25 | Traditional | PDF ↗ |
| K884619 | PACH-PEN CALCULATOR | Oculab, Inc. | 1989-02-02 | Traditional | PDF ↗ |
| K883855 | PREDICTOR II SIGNAL AVERAGING ECG | Corazonix Corp. | 1988-11-03 | Traditional | PDF ↗ |
| K880301 | 3000 PHYSIOLOGICAL MONITOR | Datascope Corp. | 1988-08-19 | Traditional | PDF ↗ |
| K880258 | WITT BIOMEDICAL VX-80 | Witt Biomedical Corporation | 1988-06-16 | Traditional | PDF ↗ |
| K880696 | MX1002 CABLE-CAL TM | Medex, Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K875167 | HORIZON 9000 | Mennen Medical, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K872529 | THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 | American Edwards Laboratories | 1987-09-15 | Traditional | PDF ↗ |
| K870375 | MODEL 617 CARDIAC OUTPUT COMPUTER | Omnimed B.V. | 1987-06-16 | Traditional | PDF ↗ |
| K871659 | IMS-2000S STRESS MONITOR | Integrated Medical Systems, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K870934 | IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM | Integrated Medical Systems, Inc. | 1987-05-06 | Traditional | PDF ↗ |
| K865101 | SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM | Spectramed, Inc. | 1987-04-20 | Traditional | PDF ↗ |
| K861505 | HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER | American Medical Equipment, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K861543 | CARDIOMAX-II | Columbus Instruments Intl. Corp. | 1987-03-10 | Traditional | PDF ↗ |
| K854371 | MTC 6210A CARDIAC OUTPUT COMPUTER | Nihon Kohden America, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K862261 | KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263 | Kontron Instruments, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K862808 | BIOMA 2000 | E.B.S., Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K863153 | MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH | Ocg Technology, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K863308 | 2200I PHYSIOLOGICAL MONITOR | Datascope Corp. | 1987-01-02 | Traditional | PDF ↗ |
| K863230 | D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM | Dextra Medical, Inc. | 1986-11-25 | Traditional | PDF ↗ |
| K863231 | D100 COMPUTER CARDIAC ANALYSIS SYSTEM | Dextra Medical, Inc. | 1986-11-25 | Traditional | PDF ↗ |
| K861092 | MODEL SP1465 CARDIAC OUTPUT COMPUTER | Gould, Inc. | 1986-08-18 | Traditional | PDF ↗ |
| K861437 | QMED SYSTEM 2150 | Qmed, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K860015 | MODIFIED CHERNE CAD DETECTOR | Cherne Industries, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K853018 | MODEL 3000 OPTICATH COMPUTER | Oximetrix, Inc. | 1986-01-13 | Traditional | PDF ↗ |
| K854136 | ARRHYTHMIA REVIEW STATION | Marquette Electronics, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K852900 | CVERNE CAD DETECTOR | Cherne Industries, Inc. | 1985-09-25 | Traditional | PDF ↗ |
| K841967 | DESERET THERMODILUTION CARDIAC OUTPUT | Parke-Davis Co. | 1985-08-19 | Traditional | PDF ↗ |
| K834059 | FUKUDA DENSHI EH-11 | Fukuda Denshi USA, Inc. | 1985-06-21 | Traditional | PDF ↗ |
| K844116 | CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC | Critikon Company, LLC | 1985-05-28 | Traditional | PDF ↗ |
| K844997 | IAI PROGRAM-COMPUTER PROGRAM | Intl. Acoustics, Inc. | 1985-04-09 | Traditional | PDF ↗ |
| K850568 | MODEL 78231D CARDIAC OUTPUT MODULE | Hewlett-Packard Co. | 1985-04-09 | Traditional | PDF ↗ |
Product code DXG · Class II · Cardiovascular. Data: openFDA.