Panels › Cardiovascular › Product code DXG · Class 2
Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation 870.1435
1510(k)s in 12 months (177 all time)
0recalls in 12 months (14 all time)
14recalls that name a 510(k)
Top companies in DXG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 2026 | K253092 | Argos Infinity (Rev. 1.0) Retia Medical Systems, Inc. | DXG |
| Sep 26, 2025 | K251275 | VitalStream ART Connect; VitalStream-Hemo Caretaker Medical | DXG |
| Dec 20, 2023 | K232048 | Cogent Hemodynamic Monitoring System; Cogent HMS Icu Medical | DXG |
| Nov 23, 2021 | K212529 | Hypotension Decision Assist Model HDA-OR2 Directed Systems, Ltd., GB | DXG |
| Apr 30, 2020 | K192169 | PulsioFlex Monitoring System with ProAQT Sensor Pulsion Medical Systems SE, DE | DXG |
| Dec 17, 2019 | K193179 | EV1000 Clinical Platform Edwards Lifesciences, LLC | DXG |
| Nov 27, 2019 | K190955 | Hypotension Decision Assist Directed Systems, Ltd., GB | DXG |
| Dec 13, 2018 | K181372 | Argos Retia Medical, LLC | DXG |
| Jan 18, 2018 | K172259 | PulsioFlex Monitoring System Pulsion Medical Systems SE, DE | DXG |
| Jun 5, 2017 | K163334 | LiDCOunity v2 Hemodynamic Monitor Lidco, Ltd., GB | DXG |
| Mar 17, 2016 | K152935 | LiDCOunity Monitor Lidco, Ltd., GB | DXG |
| Jan 29, 2015 | K134051 | TRANSONIC ELSA SYSTEM Transonic Systems, Inc. | DXG |
| Sep 17, 2014 | K134035 | TRANSONIC HCM 103 SYSTEM Transonic Systems, Inc. | DXG |
| Sep 16, 2014 | K140017 | TRANSONIC HCM 102 SYSTEM Transonic Systems, Inc. | DXG |
| Aug 1, 2014 | K132892 | TEBCO-W Bomed, Inc. | DXG |
| May 22, 2014 | K131892 | EV1000 CLINICAL PLATFORM Edwards Lifesciences, LLC | DXG |
| May 22, 2014 | K131588 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR Edwards Lifesciences, LLC | DXG |
| Jan 16, 2014 | K132528 | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES GE Healthcare Finland Oy, FI | DXG |
| Nov 5, 2013 | K122400 | CARDIOX FLOW DETECTION SYSTEM Cardiox Corp. | DXG |
| Aug 28, 2013 | K131048 | LIDCO CNAP MODULE Lidco, Ltd., GB | DXG |
| Mar 20, 2013 | K122247 | LIDCORAPID V2 MONITOR Lidco, Ltd., GB | DXG |
| Sep 7, 2012 | K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM Transonic Systems, Inc. | DXG |
| Aug 2, 2012 | K122121 | PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE Pulsion Medical Systems SE | DXG |
| Sep 22, 2011 | K112448 | PULSIOFLEX Pulsion Medical Systems, Inc. | DXG |
| Jun 14, 2011 | K110597 | EV1000 CLINICAL PLATFORM Edwards Lifesciences | DXG |
| May 17, 2011 | K103094 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR Edwards Lifesciences, LLC | DXG |
| Dec 7, 2010 | K100709 | EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M Edwards Lifesciences, LLC | DXG |
| Jul 2, 2010 | K101487 | CHEETAH NICOM SYSTEM Cheetah Medical, Inc. | DXG |
| Jun 18, 2010 | K091786 | PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) Pulsion Medical Systems AG | DXG |
| May 12, 2010 | K092219 | NAVIGATOR CLINICAL GUIDENCE SYSTEM Applied Physiology Pty , Ltd. | DXG |
| Dec 9, 2008 | K082308 | MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR Edwards Lifesciences, LLC | DXG |
| Sep 8, 2008 | K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM Transonic Systems, Inc. | DXG |
| Jul 22, 2008 | K081776 | CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM Omega Critical Care Limited, GB | DXG |
| Jan 18, 2008 | K071631 | NICOM ELECTRODES Cheetah Medical, Inc. | DXG |
| Jan 3, 2008 | K073113 | INFINITY PICCO POD, MODEL MS16734 Draeger Medical Systems, Inc. | DXG |
| Oct 18, 2007 | K072735 | PULSION PICCO-2, MODEL 8500 Pulsion Medical Systems AG | DXG |
| Aug 22, 2006 | K062134 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR Edwards Lifesciences, LLC | DXG |
| Jul 25, 2006 | K060898 | PULSION PICCO PLUS, MODEL 8100 Pulsion Medical Systems AG | DXG |
| Apr 25, 2006 | K060660 | EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER Edwards Lifesciences, LLC | DXG |
| Dec 9, 2004 | K043103 | VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 Edwards Lifesciences, LLC | DXG |
| Nov 12, 2004 | K042144 | NICOM Cheetah Medical, Inc., IL | DXG |
| Apr 26, 2004 | K040287 | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR Edwards Lifesciences, LLC | DXG |
| Oct 15, 2003 | K032997 | MODIFICATION TO: HORIZON 9000WS Mennen Medical , Ltd., IL | DXG |
| Jan 9, 2003 | K023960 | LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 Lidco, Ltd., GB | DXG |
| Jul 12, 2002 | K021874 | ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 Abbott Laboratories | DXG |
| Jun 14, 2001 | K010049 | PULSECO HEMODYNAMIC MONITOR CM71 Lidco, Ltd., GB | DXG |
| Sep 20, 2000 | K000664 | VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS Baxter Healthcare Corp | DXG |
| Jun 13, 2000 | K001762 | PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM Pulsion Medical Systems, Inc. | DXG |
| Jun 24, 1999 | K991775 | MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS Mennen Medical, Inc., IL | DXG |
| Jan 8, 1999 | K962918 | LIDCO SYSTEM Lidco, Ltd. | DXG |
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