3,600 results · 19ms · Sources: EU EUDAMED, US FDA

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A)

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EnVeo R, EnVeo PRO, Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R, PRO and PRO+ Systems

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR and TECNIS 1-Piece IOL, TECNIS OpticBlue IOL, TECNIS Multifocal 1-Piece IOL, TECNIS Symfony Extended Range of Vis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R/PRO/PRO+ Systems

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·Access Hybritech PSA

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·PulseSelect™ Pulsed Field Ablation (PFA) system

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 THIRD GENERATION PSA

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·FARAWAVE Pulsed Field Ablation Catheter

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT TOTAL PSA (LN 6C06)

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT Total PSA / Alinity i Total PSA