ClearanceBrief
Panels › Cardiovascular › Product code MHX · Class 2

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Regulation 870.1025

16510(k)s in 12 months (431 all time)
36recalls in 12 months (294 all time)
277recalls that name a 510(k)
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Top companies in MHX

DateFirm and productCodeLinked 510(k)
Aug 15, 2011Spacelabs Healthcare, Llc
Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in
Terminated
MHXK093501
Aug 2, 2011Spacelabs Healthcare, Llc
Vital Sign elance Monitor, Model 93300 Spacelabs Healthcare, Llc. A vital signs patient monitor with arrhythmia detection.
Terminated
MHXK093501
Jun 20, 2011Spacelabs Healthcare, Llc
The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's vent
Terminated
MHXK031124
Jun 17, 2011Philips Healthcare Inc.
Philips SureSigns VM Series Patient Monitors: VM4, VM6, VM 8: Model Part Numbers VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971 VM6 863064, 863065, 453564024421, 453564022001, 453
Terminated
MHXK101067
May 19, 2011Philips Healthcare Inc.
Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, para
Terminated
MHXK081983
May 3, 2011Spacelabs Healthcare, Llc
Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-0
Terminated
MHXK102422
Apr 8, 2011GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B850 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare f
Terminated
MHXNone listed
Apr 8, 2011GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare f
Terminated
MHXK102239
Apr 8, 2011GE Healthcare, LLC
GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE M
Terminated
MHXK092027
Mar 3, 2011GE Healthcare, LLC
GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and moni
Terminated
MHXK080251
Jan 27, 2011Philips Healthcare Inc.
Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PA
Terminated
MHXK081983
Nov 15, 2010GE Healthcare, LLC
Power supply boards on Dash 3000, 4000 and 5000 Monitors. GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223.
Terminated
MHXK073462
Nov 15, 2010GE Healthcare, LLC
GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module.
Terminated
MHXK071073
Aug 26, 2010Draeger Medical Systems, Inc.
Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
Terminated
MHXK070566
Aug 26, 2010Draeger Medical Systems, Inc.
Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
Terminated
MHXK070566
Aug 25, 2010GE Healthcare, LLC
CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.
Terminated
MHXK092027
Aug 10, 2010Philips Healthcare Inc.
Philips Intellivue Patient Monitor Model MP70 (M8007A)
Terminated
MHXK093268
Aug 10, 2010Philips Healthcare Inc.
Philips Intellivue Patient Monitor Model MP60 (M8005A)
Terminated
MHXK093268
Jun 11, 2010Ge Healthcare, Llc
GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE " Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within
Terminated
MHXNone listed
Jun 10, 2010Mindray DS USA, Inc., dba Datascope Patient Monitoring
Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of var
Terminated
MHXK091834
Dec 29, 2009Draeger Medical, Inc.
Delta/Delta XL Monitors with Omega S Package
Terminated
MHXK070566
Nov 23, 2009Philips Healthcare Inc.
SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predictive Temperature only; SPo2 only; SPo2 and Recorder only; SPo2 and Predictive Temperature only; or
Terminated
MHXK090483
Nov 23, 2009Philips Healthcare Inc.
SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM monitors at 1 time Part number: 863069,863070,863071,863072,863073,863074,453564041251,453564041261, 45
Terminated
MHXK070588
Nov 23, 2009Philips Healthcare Inc.
SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedsi
Terminated
MHXK090483
Sep 11, 2009Spacelabs Healthcare, Incorporated
Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The
Terminated
MHXK090556
Jun 1, 2009GE Healthcare
GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring.
Terminated
MHXK032369
May 27, 2009Mindray DS USA, Inc., dba Datascope Patient Monitoring
Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. Datascope Patient Monitoring Intended for use in a fixed location, in the healthcare fa
Terminated
MHXK031760
Sep 16, 2008CAS Medical Systems, Inc.
740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740
Terminated
MHXK033048
Sep 16, 2008Philips Medical Systems
Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, reco
Terminated
MHXK052707
Jan 17, 2008Datascope Corporation
Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ
Terminated
MHXNone listed
Dec 11, 2007Philips Medical Systems
Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J
Terminated
MHXK062271
Sep 5, 2007Philips Medical Systems
Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169
Terminated
MHXK062271
Dec 19, 2006Draeger Medical, Inc.
Infinity Docking Station (IDS) (transportable patient monitor) Repair Kit, part number 7262814
Terminated
MHXNone listed
Dec 19, 2006Draeger Medical, Inc.
Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
Terminated
MHXK053484
Dec 19, 2006Draeger Medical, Inc.
Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
Terminated
MHXK060039
Oct 21, 2006Ge Healthcare
ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver ac
Terminated
MHXK033365
Oct 20, 2006Ge Healthcare
GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The re
Terminated
MHXK032369
Jan 24, 2006Datascope Corp
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
Terminated
MHXK031760
Jul 20, 2004GE Medical Systems Information Technologies
Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEX
Terminated
MHXNone listed
Jul 20, 2004Datex-Ohmeda Inc
Datex-Ohmeda Cardiocap/5 Patient Monitors
Terminated
MHXK012837
K992323
Dec 18, 2003General Electric Medical Systems Information Technology
Solar 9500 Information Monitor with software version 3A.
Terminated
MHXK030575
Aug 21, 2003Hill-Rom Co., Inc.
Integris Monitor Arm, model P997-03.
Terminated
MHXNone listed
Aug 21, 2003Hill-Rom Co., Inc.
Integris Monitor Arm, model P997-01.
Terminated
MHXNone listed
Aug 21, 2003Hill-Rom Co., Inc.
Integris Monitor Arm; model P997-04
Terminated
MHXNone listed

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