323 results · 8ms · Sources: EU EUDAMED, US FDA

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Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS 011 & 011B IRIDOCAPSULAR IOLS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BILEAFLET-CENTER OPENING CARDIAC VALVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EMBLEM S-ICD PG models A209 and A219.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·S-ICD (Subcutaneous-ICD) Telemetry Wand

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Subcutaneous Implantable Cardioverter Defibrillator

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BILEAFLET-CENTER OPENING CARDIAC VALVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Subcutaneous Implantable Defibrillator (S-ICD) EMBLEM MRI, S-ICD Gen 2.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ST JUDE MEDICAL MECHANICAL HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM MASTERS SERIES AORTIC VALVED GRAFT (MODEL CAVGJ), AND THE SJM MASTERS HP VALVED GRAFT (MODEL VAVGJ)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Subcutaneous Implantable Defibrillator (S-ICD) System

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM MECHANICAL HEART VALVE, MASTER SERIES COATED AORTIC VALVED GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BILEAFLET-CENTER OPENING CARDIAC VALVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EMBLEM SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD)

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SUBCUTANEOUS ICD DEVICES: EMBLEM.

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Mechanical Heart Valve