SMITH S-100 TIME & TEMPERATURE CONTROL

FDA 510(k)

FDA Class 2 ·Radiology

Disposable General Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

Project E Beauty LED Light Therapy Mask (Model: PE730)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

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

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

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

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid Cochlear Implant System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid L24 Implant System

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Pre-Market Approval

FDA Class 3 ·OPRA Implant System

Gastric Emptying Breath Test

FDA Pre-Market Approval

FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 HYBRID SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

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 ·NUCLEUS 24 HYBRID SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 HYBRID SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

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

Gastric Emptying Breath Test

FDA Pre-Market Approval

FDA Class 3 ·13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid Cochlear Implant

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid Cochlear Implant

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Hybrid System