Home › Device types › DQK
Computer, Diagnostic, Programmable
FDA product code DQK · Class 2 · Cardiovascular
1,295
Registered devices
4,558
Adverse events
125
Recalls
439
510(k) clearances
Devices with this code
RHYTHMIA HDx™ — BOSTON SCIENTIFIC CORPORATIONAcQMap — ACUTUS MEDICAL, INC.HolterCare — SCOTTCARE CORPORATION, THEiLab™ — BOSTON SCIENTIFIC CORPORATIONMediGuide™ — ST. JUDE MEDICAL, INC.Change Healthcare Cardiology ECG Management — Change Healthcare Canada CompanyiLab Ultrasound Imaging System — BOSTON SCIENTIFIC CORPORATIONCAM — GE Medical Systems Information Technologies, Inc.Anchors(30) for Endo PAT 2000 — ITAMAR MEDICAL LTDEASYSCOPE — MICROPORT CRM SRLSpacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INCNA — GE Medical Systems Information Technologies, Inc.Ablamap® System — Ablacon Inc.SJM™ — ST. JUDE MEDICAL, INC.EnSite™ — ST. JUDE MEDICAL, INC.AcQMap — ACUTUS MEDICAL, INC.EnSite™ Velocity™ — ST. JUDE MEDICAL, INC.MediGuide™ — ST. JUDE MEDICAL, INC.CARESCAPE B450 — GE Healthcare Finland OyZurich Medical Accessory Cable — ZURICH MEDICAL INC.Xper Information Management System — Philips Medical Systems Nederland B.V.LABSYSTEM™ PRO — BOSTON SCIENTIFIC CORPORATIONNA — ST. JUDE MEDICAL, INC.MAC — GE Medical Systems Information Technologies, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-30 | GE Medical Systems Information Technologies Inc | Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically signifi |
| 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 |
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