Computer, diagnostic, programmable

FDA product code DQK · Class 2 · 142 devices · 2,021 reports · 19 deaths reported · 38 devices named in recalls

• EnSite™ ENSITE-DWS-3.1

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-SW-4.0.1

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  2 reports
• LABSYSTEM™ PRO M0042002034R0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• FFR Link H749555100R0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• RHYTHMIA HDx™ M004RH40100

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• LABSYSTEM™ PRO M00420020810

  Boston Scientific Corporation · Computer, diagnostic, programmable
  2 reports
• Carto 3 CR3434CT

  Biosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• Rhythmia HDx™ Mapping System M004RAPATCH20

  Boston Scientific Corporation · Computer, diagnostic, programmable
  1 report
• AVVIGO™ Guidance System II H749009881C0

  Boston Scientific Corporation · Computer, diagnostic, programmable
  1 report
• IOPS Mobile Cart MC-1

  Centerline Biomedical, Inc. · Computer, Diagnostic, Programmable
  1 report
• AcQMap 800500

  Acutus Medical, Inc. · Computer, Diagnostic, Programmable
  1 report
• Synapse Select 4.X.X

  Fujifilm Healthcare Americas Corporation · Computer, Diagnostic, Programmable
  1 report
• KODEX-EPD System 733015

  Philips Medical Systems Nederland B.V. · Computer, Diagnostic, Programmable
  1 report
• EP-WorkMate™ WM-01-1203

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• EnSite™ Velocity

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite™ H421054

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite™ Velocity ArrayLink

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• WorkMate Claris™ H700131

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• NA C12916

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• NA C12616

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• EnSite Precision™ H702469

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• EnSite™ ENSITE-PRSBACK-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-ACBL-160-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-FF-ABRKT-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-R-DWS-1.1

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite Precision™ EN0020-P

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-SYSTEM-201

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-TFM-3.1

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-SW-05

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-DWS-05

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  1 report
• NA H749I5033R0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• iLab Ultrasound Imaging System H749ILAB120INS0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• LABSYSTEM™ PRO M00420020290

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• RHYTHMIA HDx™ M004RH1020R0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• RHYTHMIA HDx™ M004RH20020

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• Carto 3 CB3410CT

  Biosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• Carto 3 CB3412CT

  Biosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• Carto 3 CB3434CT

  Biosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• Carto 3 CY1212CT

  Biosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• Cardea SOLO M300-5

  Cardiac Insight, Inc. · Computer, Diagnostic, Programmable
  1 report
• Change Healthcare Cardiology ECG Management 14.1.1

  Change Healthcare Israel Ltd · Computer, Diagnostic, Programmable
  1 report
• McKesson Cardiology ECG Management 13.2.1

  Change Healthcare Canada Company · Computer, Diagnostic, Programmable
  1 report