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)
Get daily alerts for DQKSample briefCSV

Top companies in DQK

Company510(k)sRecalls
Biosense Webster, Inc.347
Boston Scientific1524
Siemens Medical Solutions USA, Inc.525
St Jude Medical231
Ge Medical Systems Information Technologies185
Edwards Lifesciences152
Merge Healthcare Incorporated215
ABBOTT MEDICAL140
Acutus Medical, Inc.120
Spacelabs Healthcare48
Decided510(k)Device and applicantCode
Nov 11, 2021K213364EnSite X EP System
ABBOTT MEDICAL
DQK
Nov 9, 2021K211546Vektor Computational ECG Mapping System (vMap)
Vektor Medical, Inc.
DQK
Nov 3, 2021K210543IM007
Implicity, Inc.
DQK
Oct 29, 2021K213264CARTO 3 EP Navigation System Version 7.2
Biosense Webster, Inc.
DQK
Oct 22, 2021K212061EnSite X EP System
Abbott
DQK
Oct 20, 2021K212490AVVIGO Guidance System II
Boston Scientific Corporation
DQK
Aug 31, 2021K203084Ablamap Software
Ablacon, Inc.
DQK
Aug 27, 2021K212345AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Aug 16, 2021K201094iMap 3D Mapping & Navigation System (iMap System)
Cardionxt, Inc.
DQK
Aug 5, 2021K210680AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Jul 8, 2021K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform
Edwards Lfesciences
DQK
Jun 25, 2021K210889iLab Polaris Multi-Modality Guidance System
Boston Scientific Corporation
DQK
May 28, 2021K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
Edwards Lifesciences, LLC
DQK
May 21, 2021K202527Zio ECG Utilization Software (ZEUS) System
iRhythm Technologies, Inc.
DQK
Mar 26, 2021K201921Spacelabs Lifescreen PRO Analyzer
Spacelabs Healthcare, Ltd., GB
DQK
Mar 11, 2021K210392WorkMate Claris System
Abbott
DQK
Dec 17, 2020K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter
Philips Medical System Nederland B.V., NL
DQK
Dec 8, 2020K202189Graffiti
Ge Medical Systems Information Technologies, Inc.
DQK
Dec 1, 2020K201015AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Nov 25, 2020K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor E
ABBOTT MEDICAL
DQK
Nov 25, 2020K200484CARTO® 3 EP Navigation System with Signal Processing Unit
Biosense Webster, Inc.
DQK
Nov 16, 2020K201060Cordiana Dx16
Cordiana Medical Informatics AG, CH
DQK
Nov 13, 2020K201881CoroFlow Cardiovascular System
Coroventis Research AB, SE
DQK
Nov 12, 2020K201985KardiaAI
AliveCor, Inc.
DQK
Oct 1, 2020K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
Edwards Lifesiences, LLC
DQK
Sep 16, 2020K201298VX1
Volta Medical, FR
DQK
Sep 14, 2020K200313VIVO
Catheter Precision, Inc.
DQK
Jul 23, 2020K201713AVVIGO Guidance System
Boston Scientific Corporation
DQK
Jun 26, 2020K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
ABBOTT MEDICAL
DQK
Jun 26, 2020K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Displ
ABBOTT MEDICAL
DQK
May 29, 2020K201178iLab Polaris Multi-Modality Guidance System
Boston Scientific
DQK
Feb 11, 2020K193013AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Nov 27, 2019K192438Rhythmia HDxTM Mapping System
Boston Scientific Corporation
DQK
Sep 6, 2019K191392AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Aug 29, 2019K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
Edwards Lifesciences, LLC
DQK
Aug 23, 2019K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
iRhythm Technologies, Inc.
DQK
Jul 20, 2019K191660CARTO 3 EP Navigation System, Version 7.1 and Accessories
Biosense Webster, Inc.
DQK
Jul 2, 2019K191008iLab Polaris Multi-Modality Guidance System
Boston Scientific Corporation
DQK
Jun 24, 2019K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad
Centerline Biomedical, Inc.
DQK
Jun 14, 2019K183195VIVO
Catheter Precision, Inc.
DQK
Jun 13, 2019K191089Edwards Pressure Cable
Edwards Lifesciences, LLC
DQK
Apr 2, 2019K190131AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Mar 11, 2019K181823KardiaAI
AliveCor, Inc.
DQK
Mar 7, 2019K182344RhythmAnalytics
Biofourmis Singapore Pte., Ltd., SG
DQK
Mar 1, 2019K183266EP-TRACER System
Schwarzer Cardiotek GmbH, DE
DQK
Feb 28, 2019K183099QUANTIEN Measurement System
St. Jude Medical (Now Abbott Medical)
DQK
Feb 7, 2019K181577AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Dec 12, 2018K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Abbott
DQK
Nov 19, 2018K180432AI-ECG Platform
Shenzhen Carewell Electronics., Ltd., CN
DQK
Nov 16, 2018K180881HemoSphere Advanced Monitor, HemoSphere Pressure Cable
Edwards Lifesciences, LLC
DQK

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.