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