Home › Device types › DQK
Computer, Diagnostic, Programmable
FDA product code DQK · Class 2 · Cardiovascular
1,270
Registered devices
4,441
Adverse events
124
Recalls
435
510(k) clearances
Devices with this code
MediGuide™ — ST. JUDE MEDICAL, INC.HemoSphere Vita — Edwards Lifesciences LLCMediGuide™ — ST. JUDE MEDICAL, INC.EnSite™ — ST. JUDE MEDICAL, INC.CardioInsight™ — MEDTRONIC, INC.Premier Heart MCG — PREMIER HEART, LLCAcumen IQ Sensor with Vamp with TruWave — Edwards Lifesciences LLCRhythmia™ Mapping System — BOSTON SCIENTIFIC CORPORATIONN/A — Biosense Webster IncCARESCAPE B850 — GE Healthcare Finland OyWorkMate™ Unity™ — ST. JUDE MEDICAL, INC.RHYTHMIA HDx™ — BOSTON SCIENTIFIC CORPORATIONWorkMate Claris™ — ST. JUDE MEDICAL, INC.EnSite™ Velocity™ — ST. JUDE MEDICAL, INC.EnSite™ — ST. JUDE MEDICAL, INC.iLab™ Polaris Multi-Modality Guidance System — BOSTON SCIENTIFIC CORPORATIONEP-TRACER — CardioTek B.V.NA — ST. JUDE MEDICAL, INC.Advisor™ — ST. JUDE MEDICAL, INC.WorkMate™ — ST. JUDE MEDICAL, INC.Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INCOptiMap™ Workstation — Cortex, Inc.Innocor — Innovision ApSMAC — GE Medical Systems Information Technologies, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-24 | GE Medical Systems Information Technologies Inc | Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head |
| 2025-09-16 | Spacelabs Healthcare, Ltd. | Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured |
| 2025-08-11 | Merge Healthcare, Inc. | Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units |
| 2025-04-11 | Centerline Biomedical Inc | Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire. |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Im |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Im |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Im |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Im |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Im |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Im |
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