ClearanceBrief
Panels › Cardiovascular › Product code DPS · Class 2

Electrocardiograph

Regulation 870.2340

8510(k)s in 12 months (580 all time)
4recalls in 12 months (98 all time)
89recalls that name a 510(k)
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Top companies in DPS

DateFirm and productCodeLinked 510(k)
Aug 25, 2026Midmark Corporation
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Open, Classified
DPSK103640
Aug 14, 2026Philips North America Llc
Cardiac Workstation 7000. Product Number: 860441.
Open, Classified
DPSK241556
Aug 14, 2026Philips North America Llc
Cardiac Workstation 5000. Product Number: 860439.
Open, Classified
DPSK241556
Aug 4, 2026GE Medical Systems Information Technologies Inc
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Open, Classified
DPSK173830
Oct 22, 2025GE Medical Systems, LLC
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
Open, Classified
DPSK173830
Oct 16, 2025Philips North America
Cardiac Workstation 7000; Model Number: 860441;
Open, Classified
DPSK241556
Oct 16, 2025Philips North America
Cardiac Workstation 5000; Model Number: 860439;
Open, Classified
DPSK241556
Apr 14, 2025Baxter Healthcare Corporation
Welch Allyn CP150 Electrocardiograph:
Open, Classified
DPSK141582
Dec 23, 2024Braemar Manufacturing, LLC
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Open, Classified
DPSNone listed
Nov 7, 2024Baxter Healthcare Corporation
Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
Open, Classified
DPSK152944
Nov 7, 2024Baxter Healthcare Corporation
Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
Open, Classified
DPSK120865
Nov 7, 2024Baxter Healthcare Corporation
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
Open, Classified
DPSK152944
Aug 27, 2024Schiller, Ag
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Open, Classified
DPSK183425
Jul 10, 2024Baxter Healthcare Corporation
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardia
Open, Classified
DPSK141582
Jan 10, 2024Baxter Healthcare Corporation
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-5
Open, Classified
DPSNone listed
Jan 10, 2024Baxter Healthcare Corporation
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KI
Open, Classified
DPSK152944
Jan 10, 2024Baxter Healthcare Corporation
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT
Open, Classified
DPSK152944
Mar 22, 2023Withings
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Open, Classified
DPSK201456
Jan 24, 2023Baxter Healthcare Corporation
Baxter Electrocardiograph, ELI 380 -DCS21
Terminated
DPSK142105
Sep 3, 2021Welch Allyn Inc Mortara
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-
Open, Classified
DPSK122073
Mar 31, 2021Welch Allyn Inc Mortara
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Terminated
DPSNone listed
Mar 31, 2021Welch Allyn Inc Mortara
Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric po
Terminated
DPSK173765
Mar 31, 2021Welch Allyn Inc Mortara
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Terminated
DPSK142105
Mar 31, 2021Welch Allyn Inc Mortara
ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Terminated
DPSK122073
Dec 7, 2020GE Healthcare, LLC
MAC VU360, Electrocardiograph
Terminated
DPSK173830
Nov 11, 2020WELCH ALLYN, INC/MORTARA
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from e
Terminated
DPSNone listed
May 19, 2020Philips North America, LLC
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designe
Terminated
DPSK090483
Apr 29, 2020WELCH ALLYN, INC/MORTARA
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GR
Terminated
DPSNone listed
Apr 29, 2020WELCH ALLYN, INC/MORTARA
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
Terminated
DPSK041607
Apr 29, 2020WELCH ALLYN, INC/MORTARA
Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquis
Terminated
DPSK152944
Apr 29, 2020WELCH ALLYN, INC/MORTARA
Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor
Terminated
DPSK173765
Apr 29, 2020WELCH ALLYN, INC/MORTARA
S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AH
Terminated
DPSK160685
Apr 29, 2020WELCH ALLYN, INC/MORTARA
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LE
Terminated
DPSK974149
Apr 29, 2020WELCH ALLYN, INC/MORTARA
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient
Terminated
DPSK081800
Apr 29, 2020WELCH ALLYN, INC/MORTARA
H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10
Terminated
DPSK050896
Apr 29, 2020WELCH ALLYN, INC/MORTARA
ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.
Terminated
DPSK093339
Apr 29, 2020WELCH ALLYN, INC/MORTARA
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescr
Terminated
DPSK092663
K100127 +3
Jan 9, 2019Philips North America, LLC
PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Open, Classified
DPSK113144
Jan 9, 2019Philips North America, LLC
PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Open, Classified
DPSK113144
Jan 9, 2019Philips North America, LLC
PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Open, Classified
DPSK113144
Jan 9, 2019Philips North America, LLC
PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Open, Classified
DPSK113144
Jan 9, 2019Philips North America, LLC
PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients
Open, Classified
DPSK113144
Jan 9, 2019Philips North America, LLC
PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Open, Classified
DPSK113144
Jan 9, 2019Philips North America, LLC
PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Open, Classified
DPSK113144
Jan 9, 2019Philips North America, LLC
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Open, Classified
DPSK113144
Jan 9, 2019Philips North America, LLC
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Open, Classified
DPSK113144
Jun 12, 2015Mortara Instrument, Inc
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from ea
Terminated
DPSK142105
Jan 13, 2012Del Mar Reynolds Medical, Ltd.
Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare faci
Terminated
DPSK090367
Oct 12, 2011Edan Instruments, Inc.
ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series
Terminated
DPSK091513
Jun 17, 2011Philips Healthcare Inc.
Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564041261, VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301 The Sure
Terminated
DPSK090483

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