Stimulator, Thalamic, Epilepsy, Implanted

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC DBS THERAPY FOR EPILEPSY

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Medtronic DBS Therapy for Epilepsy

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SUPARTZ

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification

FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A

Placental Alpha Microglobulin-1 Immunoassay

FDA classification

FDA Class 3 ·Placental Alpha Microglobulin-1 Immunoassay

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH® SF Catheter

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA Pre-Market Approval

FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM STERILE SPONGE

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS-TC/U LITHOTRIPTER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS LITHOTRIPTER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES