806 results · 28ms · Sources: EU EUDAMED, US FDA

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA)

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA DR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI SURESCAN

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL CI System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL Cochlear Implant

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL CONCERT IMPLANT

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·MEL 80 Excimer Laser

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL Cochlear Implants