117 results · 62ms · Sources: EU EUDAMED, US FDA

SavvyWire

FDA 510(k)
FDA Class 2 ·Cardiovascular

PacePro Wire

FDA 510(k)
FDA Class 2 ·Cardiovascular

OptoMonitor II

FDA 510(k)
FDA Class 2 ·Cardiovascular

OptoMonitor 3

FDA 510(k)
FDA Class 2 ·Cardiovascular

OptoMonitor

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Opsens Inc.·1 device

OptoMonitor 3

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Opsens Inc.·1 device

OptoWire Deux Pressure Guidewire with Gauge Connector

Basic UDI-DI
EU MDD · Eu Md Class 3 ·Opsens Inc.·1 device

OptoWire III Pressure Guidewire

Basic UDI-DI
EU MDD · Eu Md Class 3 ·Opsens Inc.·1 device

CE 597147

Certificate
MDD Annex II (excluding section 4)·Opsens Inc.·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

CE 597148

Certificate
MDD Annex II (excluding section 4)·Opsens Inc.·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

Opsens B.V.

Importer
🇳🇱 Netherlands·1 Manufacturer

ProCardia Medical sp. z o.o.

Importer
🇵🇱 Poland·1 Manufacturer

TOP Medical B.V.

Importer
🇳🇱 Netherlands·6 Manufacturers

Bisping Medizintechnik GmbH

Importer
🇩🇪 Germany·13 Manufacturers

MDSS GmbH

Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices

EHY / Tray, Impression, PREFORMED

FDA registration
Open Airway Dental Solutions Australia Pty Ltd·1 product·🇦🇺 Australia

Device, anti-snoring

FDA registration
Open Airway Dental Solutions Australia Pty Ltd·1 product·🇦🇺 Australia

Device, anti-snoring

FDA registration
Open Airway Dental Solutions Australia Pty Ltd·1 product·🇦🇺 Australia

Device, anti-snoring

FDA registration
Open Airway Dental Solutions Australia Pty Ltd·1 product·🇦🇺 Australia

Device, anti-snoring

FDA registration
Open Airway Dental Solutions Australia Pty Ltd·1 product·🇦🇺 Australia