Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP)with and without InhibiZone Treatment and AMS Ambicor Inflatable Penile Prosth

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Cobalt/Crome App, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·AudioKey 1.0 and AudioLink

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus® Hybrid™ L24 Cochlear Implant System

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 Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus® 24 Cochlear Implant System

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·Nucleus® 24 Auditory Brainstem Implant System

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CONCERTO MODEL C154DWK ICD

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

CHIROFLEX II LENS MICROSERT(TM)

FDA 510(k)

FDA Class 3 ·Ophthalmic

OMS SILICONE OIL INJECTOR

FDA 510(k)

FDA Class 3 ·Ophthalmic

NIDEK DIGITAL KERATOMETER

FDA 510(k)

FDA Class 3 ·Ophthalmic

SOFTRANS INJECTOR

FDA 510(k)

FDA Class 3 ·Ophthalmic

AMER. MEDICAL OPTICS DIGITAL KERATO-

FDA 510(k)

FDA Class 3 ·Ophthalmic