Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Combi 40+ Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COCHLEAR NUCLEUS C1512 IMPLANT SYSTEM

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·Auditory Brainstem Implant

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus N22 Cochlear Implant Systems

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO System Software 9.0

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM

LM-150HT LIGHT SOURCE

FDA 510(k)

FDA Class 3 ·Unknown

GASTROTEC

FDA 510(k)

FDA Class 3 ·Unknown

Device, Antichoke, Suction

FDA classification

FDA Class 3 ·Device, Antichoke, Suction

Device, Antichoke, Tongs

FDA classification

FDA Class 3 ·Device, Antichoke, Tongs

Stimulator, Transdermal

FDA classification

FDA Class 3 ·Stimulator, Transdermal

Polymer, Natural-Absorbable Gelatin Material

FDA classification

FDA Class 3 ·Polymer, Natural-Absorbable Gelatin Material

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA classification

FDA Class 3 ·Implant, Hearing, Active, Middle Ear, Partially Implanted

Tympanostomy Tube Delivery Product With Drug

FDA classification

FDA Class 3 ·Tympanostomy Tube Delivery Product With Drug

Drug-Eluting Sinus Stent

FDA classification

FDA Class 3 ·Drug-Eluting Sinus Stent