10,000 results · 24ms · Sources: EU EUDAMED, US FDA

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ECLA GlideLight Catheter

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·PAPNET (R) TESTING SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT FOR CHILDREN

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 HYBRID SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN® Ultrasound Bone Healing System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NECLEUS 24 COCHLEAR IMPLANT SYSTEM SOFTWARE

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Auditory Brainstem Implant System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS A21-A & A21-B POSTERIOR CHAMBER INTRAOCULAR

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·I-FACTOR PEPTIDE ENHANCED BONE GRAFT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEMS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COCHLEAR NUCLEUS 24 IMPLANT SYSTEM

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Cochlear Implant System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Mobi-C Cervical Disc Prosthesis

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN ULTRASOUND BONE HEALING SYSTEM

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate