ClearanceBrief
Panels › Cardiovascular › Product code DQK · Class 2

Computer, Diagnostic, Programmable

Regulation 870.1425

29510(k)s in 12 months (442 all time)
2recalls in 12 months (125 all time)
121recalls that name a 510(k)
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Top companies in DQK

Decided510(k)Device and applicantCode
May 22, 2009K083328ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
St Jude Medical
DQK
Feb 17, 2009K083639MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
Ge Medical Systems Information Technologies
DQK
Dec 17, 2008K082421HEARTSUITE HEMODYNAMICS 7.10
Emageon, Inc.
DQK
Oct 31, 2008K072752BP LIMBO XL, BPTANGO XL, BP SALSA XL
Datadancer Medical Systems
DQK
Sep 11, 2008K082467ENSITE FUSION DYNAMIC REGISTRATION TOOL
St Jude Medical
DQK
Jun 20, 2008K081484HORIZON XVU
Mennen Medical , Ltd., IL
DQK
Dec 20, 2007K071818ENSITE FUSION DYNAMIC REGISTRATION TOOL
St Jude Medical
DQK
Nov 19, 2007K072502MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
Ge Medical Systems Information Technologies
DQK
Nov 19, 2007K072202CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
Biosense Webster, Inc.
DQK
Nov 2, 2007K072919VENDYS, MODEL 6000 B B/C
Endothelix, Inc.
DQK
Sep 7, 2007K071911CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR
Innovision A/S
DQK
Sep 7, 2007K071348EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
Mennen Medical , Ltd., IL
DQK
Aug 16, 2007K060980VENDYS MODEL 5000 B/BC
Endothelix, Inc.
DQK
May 4, 2007K070240CARTO XP EP NAVIGATION SYSTEM, VERSION 9
Biosense Webster, Inc.
DQK
May 1, 2007K070902MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
St Jude Medical
DQK
Apr 19, 2007K070254HORIZON SE
Mennen Medical , Ltd., IL
DQK
Apr 11, 2007K070706EP-WORKMATE
Ep Medsystems
DQK
Mar 15, 2007K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
Spacelabs Medical, Inc.
DQK
Feb 23, 2007K070280CARDIODAY, VERSION 2.0
Getemed Medizin- Und Informationstechnik AG
DQK
Nov 30, 2006K063277MAPMATE
Ep Medsystems, Inc.
DQK
Nov 8, 2006K061905HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0
Medcon , Ltd.
DQK
Oct 27, 2006K063113EP-WORKMATE
Ep Medsystems
DQK
Sep 15, 2006K061741MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
GE Healthcare
DQK
Apr 21, 2006K060954MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
St. Jude Medical, Inc.-Endocardial Solutions
DQK
Mar 9, 2006K053194NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
Biosense Webster, Inc.
DQK
Mar 2, 2006K051907INNOCOR
Innovision A/S
DQK
Jan 13, 2006K052976DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
GE Healthcare
DQK
Dec 22, 2005K053369MEDILOG DARWIN HOLTER ANALYSIS
Huntleigh Healthcare, GB
DQK
Nov 22, 2005K052977DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
GE Healthcare
DQK
Nov 1, 2005K052883CARDIOSERVER
Datrix
DQK
Sep 29, 2005K042681CARTO RMT EP NAVIGATION SYSTEM
Biosense Webster, Inc.
DQK
Jul 19, 2005K051026MARS HOLTER ANALYSIS WORKSTATION
Ge Medical Systems Information Technologies
DQK
Jun 29, 2005K051471CARDIODAY
Getemed Medizin- Und Informationstechnik AG
DQK
May 13, 2005K050093MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
Ge Medical Systems Information Technologies
DQK
May 4, 2005K050561WINDSURFER
Medcon , Ltd., IL
DQK
Apr 29, 2005K043604LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE
Vivometrics, Inc.
DQK
Apr 7, 2005K050225HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
Cambridge Heart, Inc.
DQK
Apr 5, 2005K050614MUSE CARDIOLOGY INFORMATION SYSTEM
Ge Medical Systems Information Technologies
DQK
Mar 21, 2005K042999CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8
Biosense Webster, Inc.
DQK
Jan 27, 2005K043564HORIZON ANGIO CATHLAB
Mennen Medical , Ltd., IL
DQK
Jan 26, 2005K041031CARDIOSTATION-100 (CS-100)
Us Clover Co.
DQK
Jan 19, 2005K042628MODIFICATION TO: RADIANALYZER, MODEL 12711
Radi Medical Systems AB, SE
DQK
Jan 13, 2005K042849CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
Cardiobiomedical Corporation
DQK
Dec 16, 2004K033266VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS
Medical Imaging Applications, LLC
DQK
Dec 3, 2004K042148HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
Ge Medical Syst. Information Technologies
DQK
Oct 22, 2004K042799QRS-CARD CARDIOLOGY SUITE
Pulse Biomedical, Inc.
DQK
Oct 20, 2004K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
Ela Medical, Inc.
DQK
Oct 15, 2004K042493ENSITE SYSTEM, MODEL EE3000
Endocardial Solutions, Inc.
DQK
Sep 22, 2004K042463HOLTER PLUS
Rozinn Electronics, Inc.
DQK
Nov 12, 2003K032519ENDO PAT 2000
Itamar Medical, IL
DQK

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