Home › Device types › JOQ
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
FDA product code JOQ · Class 2 · Cardiovascular
24
Registered devices
148
Adverse events
3
Recalls
18
510(k) clearances
Devices with this code
Bloom — Fischer MedicalBloom2 — Fischer MedicalEP-4™ — ST. JUDE MEDICAL, INC.EP-4™ — ST. JUDE MEDICAL, INC.EP-4™ — ST. JUDE MEDICAL, INC.EP-4™ — ST. JUDE MEDICAL, INC.EP-4™ — ST. JUDE MEDICAL, INC.Bloom — Fischer MedicalWorkMate Claris™ — ST. JUDE MEDICAL, INC.Micropace — MICROPACE PTY LIMITEDBloom2 — Fischer MedicalMicropace — MICROPACE PTY LIMITEDORLAB — MICROPACE PTY LIMITEDBloom — Fischer MedicalEP-4™ — ST. JUDE MEDICAL, INC.EP-4™ — ST. JUDE MEDICAL, INC.EP-4™ — ST. JUDE MEDICAL, INC.EP-4™ — ST. JUDE MEDICAL, INC.WorkMate Claris™ — ST. JUDE MEDICAL, INC.Bloom2 — Fischer MedicalEP-4™ — ST. JUDE MEDICAL, INC.StimLab — MICROPACE PTY LIMITEDBloom2 — Fischer MedicalEP-4™ — ST. JUDE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-03-23 | St. Jude Medical | Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 ca |
| 2006-04-04 | EP Medsystems | Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in us |
| 2005-01-13 | Fischer Imaging Corporation | Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.