3,165 results · 21ms · Sources: EU EUDAMED, US FDA

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA classification
FDA Class 3 ·System, Test, Her-2/Neu, Nucleic Acid Or Serum

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval
FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

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

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Rotlex IOLA MFD

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

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

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

Implant, Cochlear

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

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

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

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