Computer, Diagnostic, Pre-Programmed, Single-Function

FDA product code DXG · 170 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1435
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-19 – 2026-02-13

DXG 2026-02-13

Argos Infinity (Rev. 1.0)

Applicant Retia Medical Systems, Inc.

K number K253092

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DXG 2025-09-26

VitalStream ART Connect; VitalStream-Hemo

Applicant Caretaker Medical

K number K251275

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DXG 2023-12-20

Cogent™ Hemodynamic Monitoring System; Cogent™ HMS

Applicant Icu Medical

K number K232048

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DXG 2021-11-23

Hypotension Decision Assist Model HDA-OR2

Applicant Directed Systems, Ltd.

K number K212529

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DXG 2020-04-30

PulsioFlex Monitoring System with ProAQT Sensor

Applicant Pulsion Medical Systems SE

K number K192169

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DXG 2019-12-17

EV1000 Clinical Platform

Applicant Edwards Lifesciences, LLC

K number K193179

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DXG 2019-11-27

Hypotension Decision Assist

Applicant Directed Systems, Ltd.

K number K190955

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DXG 2018-12-13

Argos

Applicant Retia Medical, LLC

K number K181372

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DXG 2018-01-18

PulsioFlex Monitoring System

Applicant Pulsion Medical Systems SE

K number K172259

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DXG 2017-06-05

LiDCOunity v2 Hemodynamic Monitor

Applicant Lidco, Ltd.

K number K163334

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DXG 2016-03-17

LiDCOunity Monitor

Applicant Lidco, Ltd.

K number K152935

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DXG 2013-11-05

CARDIOX FLOW DETECTION SYSTEM

Applicant Cardiox Corp.

K number K122400

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DXG 2013-08-28

LIDCO CNAP MODULE

Applicant Lidco, Ltd.

K number K131048

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DXG 2013-03-20

LIDCORAPID V2 MONITOR

Applicant Lidco, Ltd.

K number K122247

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DXG 2012-09-07

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM

Applicant Transonic Systems, Inc.

K number K113821

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DXG 2012-08-02

PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE

Applicant Pulsion Medical Systems SE

K number K122121

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DXG 2011-09-22

PULSIOFLEX

Applicant Pulsion Medical Systems, Inc.

K number K112448

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DXG 2011-06-14

EV1000 CLINICAL PLATFORM

Applicant Edwards Lifesciences

K number K110597

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DXG 2011-05-17

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR

Applicant Edwards Lifesciences, LLC

K number K103094

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DXG 2010-12-07

EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M

Applicant Edwards Lifesciences, LLC

K number K100709

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DXG 2010-07-02

CHEETAH NICOM SYSTEM

Applicant Cheetah Medical, Inc.

K number K101487

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DXG 2010-06-18

PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)

Applicant Pulsion Medical Systems AG

K number K091786

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DXG 2010-05-12

NAVIGATOR CLINICAL GUIDENCE SYSTEM

Applicant Applied Physiology Pty , Ltd.

K number K092219

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DXG 2008-12-09

MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

Applicant Edwards Lifesciences, LLC

K number K082308

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DXG 2008-09-08

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM

Applicant Transonic Systems, Inc.

K number K080116

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DXG 2008-07-22

CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM

Applicant Omega Critical Care Limited

K number K081776

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DXG 2008-01-18

NICOM ELECTRODES

Applicant Cheetah Medical, Inc.

K number K071631

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DXG 2008-01-03

INFINITY PICCO POD, MODEL MS16734

Applicant Draeger Medical Systems, Inc.

K number K073113

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DXG 2007-10-18

PULSION PICCO-2, MODEL 8500

Applicant Pulsion Medical Systems AG

K number K072735

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DXG 2006-08-22

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

Applicant Edwards Lifesciences, LLC

K number K062134

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DXG 2006-07-25

PULSION PICCO PLUS, MODEL 8100

Applicant Pulsion Medical Systems AG

K number K060898

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DXG 2006-04-25

EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER

Applicant Edwards Lifesciences, LLC

K number K060660

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DXG 2004-12-09

VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2

Applicant Edwards Lifesciences, LLC

K number K043103

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DXG 2004-11-12

NICOM

Applicant Cheetah Medical, Inc.

K number K042144

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DXG 2004-04-26

VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR

Applicant Edwards Lifesciences, LLC

K number K040287

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DXG 2003-10-15

MODIFICATION TO: HORIZON 9000WS

Applicant Mennen Medical , Ltd.

K number K032997

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DXG 2003-01-09

LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70

Applicant Lidco, Ltd.

K number K023960

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DXG 2002-07-12

ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711

Applicant Abbott Laboratories

K number K021874

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DXG 2001-06-14

PULSECO HEMODYNAMIC MONITOR CM71

Applicant Lidco, Ltd.

K number K010049

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DXG 2000-09-20

VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS

Applicant Baxter Healthcare Corp

K number K000664

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DXG 2000-06-13

PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM

Applicant Pulsion Medical Systems, Inc.

K number K001762

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DXG 1999-06-24

MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS

Applicant Mennen Medical, Inc.

K number K991775

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DXG 1999-01-08

LIDCO SYSTEM

Applicant Lidco, Ltd.

K number K962918

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DXG 1997-05-14

ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)

Applicant Alexander Mfg. Co.

K number K970784

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DXG 1997-03-04

OXIMETRIX 4 COMPUTER SYSTEM

Applicant Abbott Laboratories

K number K961661

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DXG 1996-11-21

TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)

Applicant Hemo Sapiens, Inc.

K number K962128

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DXG 1996-03-08

VITAL PAK

Applicant Vital Signs, Inc.

K number K955417

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DXG 1995-03-01

EK-VIEW(TM) ECG MANAGEMENT SYSTEM

Applicant Apcot Medical Systems

K number K946115

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DXG 1995-01-06

HORIZON 9000 WS

Applicant Mennen Medical, Inc.

K number K940415

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DXG 1994-12-15

CARDIAC OUTPUT OPTION 39

Applicant Medical Data Electronics

K number K943256

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DXG 1994-11-14

CONTINUOUS CARDIAC OUTPUT SYSTEM

Applicant Abbott Laboratories

K number K932414

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DXG 1992-12-08

IQ SYSTEM

Applicant Renaissance Technology, Inc.

K number K922218

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DXG 1991-12-20

MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST

Applicant Ppg Industries, Inc.

K number K913358

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DXG 1991-02-25

INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT

Applicant Biometric Research Institute, Inc.

K number K902628

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DXG 1990-07-03

CARDIAC OUTPUT COMPUTER, MODEL COM-3

Applicant Baxter Healthcare Corp

K number K896930

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DXG 1990-06-12

SORBA MODEL CIC-1000 W/NEW ELECTRODES

Applicant Sorba Medical Systems, Inc.

K number K901926

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DXG 1990-03-14

SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH

Applicant Sorba Medical Systems, Inc.

K number K895017

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DXG 1990-03-13

NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM

Applicant Advanced Technology Laboratories, Inc.

K number K897004

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DXG 1990-01-26

SFA MODULE

Applicant Life Sciences Manufacturing, Inc.

K number K896528

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DXG 1989-08-03

SENSOCOR TM R-TEST 24OXL

Applicant Sensocor

K number K894234

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DXG 1989-06-20

CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER

Applicant Baxter Healthcare Corp

K number K893392

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DXG 1989-04-25

TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA

Applicant S & W Medico Teknik

K number K884122

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DXG 1989-02-02

PACH-PEN CALCULATOR

Applicant Oculab, Inc.

K number K884619

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DXG 1988-11-03

PREDICTOR II SIGNAL AVERAGING ECG

Applicant Corazonix Corp.

K number K883855

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DXG 1988-08-19

3000 PHYSIOLOGICAL MONITOR

Applicant Datascope Corp.

K number K880301

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DXG 1988-06-16

WITT BIOMEDICAL VX-80

Applicant Witt Biomedical Corporation

K number K880258

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DXG 1988-06-15

MX1002 CABLE-CAL TM

Applicant Medex, Inc.

K number K880696

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DXG 1988-05-31

HORIZON 9000

Applicant Mennen Medical, Inc.

K number K875167

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DXG 1987-09-15

THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2

Applicant American Edwards Laboratories

K number K872529

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DXG 1987-06-16

MODEL 617 CARDIAC OUTPUT COMPUTER

Applicant Omnimed B.V.

K number K870375

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DXG 1987-05-28

IMS-2000S STRESS MONITOR

Applicant Integrated Medical Systems, Inc.

K number K871659

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DXG 1987-05-06

IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM

Applicant Integrated Medical Systems, Inc.

K number K870934

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DXG 1987-04-20

SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM

Applicant Spectramed, Inc.

K number K865101

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DXG 1987-04-10

HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER

Applicant American Medical Equipment, Inc.

K number K861505

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DXG 1987-03-10

CARDIOMAX-II

Applicant Columbus Instruments Intl. Corp.

K number K861543

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DXG 1987-02-19

BIOMA 2000

Applicant E.B.S., Inc.

K number K862808

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DXG 1987-02-19

KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263

Applicant Kontron Instruments, Inc.

K number K862261

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DXG 1987-02-19

MTC 6210A CARDIAC OUTPUT COMPUTER

Applicant Nihon Kohden America, Inc.

K number K854371

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DXG 1987-01-06

MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH

Applicant Ocg Technology, Inc.

K number K863153

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DXG 1987-01-02

2200I PHYSIOLOGICAL MONITOR

Applicant Datascope Corp.

K number K863308

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DXG 1986-11-25

D100 COMPUTER CARDIAC ANALYSIS SYSTEM

Applicant Dextra Medical, Inc.

K number K863231

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DXG 1986-11-25

D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM

Applicant Dextra Medical, Inc.

K number K863230

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DXG 1986-08-18

MODEL SP1465 CARDIAC OUTPUT COMPUTER

Applicant Gould, Inc.

K number K861092

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DXG 1986-05-20

QMED SYSTEM 2150

Applicant Qmed, Inc.

K number K861437

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DXG 1986-04-23

MODIFIED CHERNE CAD DETECTOR

Applicant Cherne Industries, Inc.

K number K860015

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DXG 1986-01-13

MODEL 3000 OPTICATH COMPUTER

Applicant Oximetrix, Inc.

K number K853018

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DXG 1985-12-04

ARRHYTHMIA REVIEW STATION

Applicant Marquette Electronics, Inc.

K number K854136

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DXG 1985-09-25

CVERNE CAD DETECTOR

Applicant Cherne Industries, Inc.

K number K852900

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DXG 1985-08-19

DESERET THERMODILUTION CARDIAC OUTPUT

Applicant Parke-Davis Co.

K number K841967

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DXG 1985-06-21

FUKUDA DENSHI EH-11

Applicant Fukuda Denshi USA, Inc.

K number K834059

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DXG 1985-05-28

CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC

Applicant Critikon Company, LLC

K number K844116

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DXG 1985-04-09

MODEL 78231D CARDIAC OUTPUT MODULE

Applicant Hewlett-Packard Co.

K number K850568

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DXG 1985-04-09

IAI PROGRAM-COMPUTER PROGRAM

Applicant Intl. Acoustics, Inc.

K number K844997

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DXG 1985-03-06

ELECATH CARDIAC OUTPUT COMPUTER

Applicant Electro-Catheter Corp.

K number K844682

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DXG 1985-02-15

OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR

Applicant Omikron Scientific, Ltd.

K number K844277

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DXG 1985-02-13

COMPUTER

Applicant Burdick Corp.

K number K844665

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DXG 1985-02-01

CARDIAC COMPUTER SP1445

Applicant Gould, Inc.

K number K843555

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DXG 1985-01-15

RIGHT VENTRICULAR EJECTION FRACTION-

Applicant American Edwards Laboratories

K number K842105

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DXG 1985-01-14

SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER

Applicant American Edwards Laboratories

K number K841401

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DXG 1984-11-27

SCATAID

Applicant Sc Applied Technology, Inc.

K number K842706

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