Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·Ceramax Ceramic Total Hip System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN Ultrasound Bone Healing System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL PC-36CNB (TIER A)

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Intraocular Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMALENS EXTENDED WEAR CONTACT LENS

Test System, For Drugs Of Abuse

FDA classification

FDA Class 3 ·Test System, For Drugs Of Abuse

Tissue Graft Of Less Than 6mm

FDA classification

FDA Class 3 ·Tissue Graft Of Less Than 6mm

Extended Depth Of Focus Intraocular Lens

FDA classification

FDA Class 3 ·Extended Depth Of Focus Intraocular Lens

Tissue Graft Of 6mm And Greater

FDA classification

FDA Class 3 ·Tissue Graft Of 6mm And Greater

Organ Care System (Ocs) Heart System

FDA classification

FDA Class 3 ·Organ Care System (Ocs) Heart System

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA classification

FDA Class 3 ·Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA classification

FDA Class 3 ·Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA classification

FDA Class 3 ·System, Test, Tumor Marker, For Detection Of Bladder Cancer

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA classification

FDA Class 3 ·Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

FDA classification

FDA Class 3 ·Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

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

FDA classification

FDA Class 3 ·Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA classification

FDA Class 3 ·Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA classification

FDA Class 3 ·Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations