6,315 results · 21ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ACCESS IMMUNOASSAY SYSTEMS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA HAFP TEST KIT

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE IMMUNOASSAY SYSTEMS

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·Pathway Clinical Trial Cohort

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·Aspire Assist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist