1,572 results · 28ms · Sources: EU EUDAMED, US FDA

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit® PH

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Physician Programmer Cable

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Spiration Valve System Deployment Catheter and Loader

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Sensing Lead

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Upper Airway Stimulation (UAS)

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3100B HIGH-FREQUENCY OSCILLATORY VENTILATORY (HFOV)

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·ELECTROMECHANICAL ENHANCEMENT TO DRIVER

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval
FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Progel Pleural Air Leak Sealant (Progel™ PALS)

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Pre-Market Approval
FDA Class 3 ·remede® System

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Model 3028 Implantable Pulse Generator (IPG)

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR, PATIENT BOX

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR