1,087 results · 19ms · Sources: EU EUDAMED, US FDA

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS AUDITORY BRAINSTEM IMPLANT

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·PEPGEN 15

Implant, Cochlear

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH STYLET REPLACEMENT TOOL

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008

Implant, Cochlear

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COCHLEAR C1500 SERIES IMPLANTS

Prosthesis, Intervertebral Disc

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

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·ELCA and SLS/GlideLight Catheter

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·SLS II/GLIDELIGHT CATHETERS

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·SLS II/Glide Light Catheters

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ELCA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus® 22 Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (CHILDREN)

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·SLS II SPECTRANETICS LASER SHEATHS

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus AB1541 Auditory Brainstem Implant

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS COCHLEAR 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