64 results · 18ms · Sources: EU EUDAMED, US FDA

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Akreos Posterior Chamber Intraocular Lens

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD)

DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES

FDA 510(k)
FDA Class 3 ·Cardiovascular

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DA+C & DA+T SERIES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+ C SERIES PULSE GENERATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & T SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+ C & T SERIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Telemetry Wand

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+ C & T SERIES IPGS

System, Oxygen, Aqueous

FDA Pre-Market Approval
FDA Class 3 ·TherOx® DownStream® Cartridge (DSC-2)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DA+ C-SERIES AND DA+ T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DA+ C-SERIES & DA+ T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DA+C SERIES & DA+T SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C-SERIES/VITATRON DA+T SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS