24 results · 21ms · Sources: EU EUDAMED, US FDA

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof ReSTOR Posterior Chamber Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe

Intraocular Lens

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLACOTE(TM) COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

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

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH