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

Device, Electroconvulsive Therapy

FDA classification
FDA Class 3 ·Device, Electroconvulsive Therapy

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvederm Voluma® XC and Juvederm Volbella® XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVÉDERM® VOLUMA ® XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm® Voluma® XC

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Oxford Partial Knee System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM

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

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

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

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

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 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 IMUNOASSAY SYSTEMS

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND II SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM