13 results
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50ms
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Sources: EU EUDAMED, US FDA
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
FDA 510(k)
FDA Class 2
·Cardiovascular
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
FDA 510(k)
FDA Class 2
·Cardiovascular
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
FDA 510(k)
FDA Class 2
·Cardiovascular
ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
FDA 510(k)
FDA Unclassified
·Unknown
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
CV-SEMI
FDA registration
CV OPTICS USA INC·1 product·🇺🇸 United States
n.0068/QCO-D/249-2020
Certificate
MDD Annex II (excluding section 4)·Saria Mehr Co.Ltd·MTIC InterCert S.r.l.·1 Basic UDI-DI
n.0068/QCO-DM/249-2020
Certificate
MDD Annex II (excluding section 4)·Saria Mehr Co.Ltd·MTIC InterCert S.r.l.·11 Basic UDI-DIs
Arazy Group (Ireland) Ltd.
Authorized representative
🇮🇪 Ireland·17 Manufacturers·425 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Kingsmead Service B.V.
Authorized representative
🇳🇱 Netherlands·243 Manufacturers·2698 Devices