Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR BOWEL CONTROL

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Boston Orthokeratology (oprifocon A) Shaping lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Programming software modules for Orchestra Plus and SmartTouch programmers, CPR4 Telemetry head accessory for SmartTouch

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Air Optix Aqua for Astigmatism / Aqua Multifocal / plus Hydraglyde / plus Hydraglyde Multifocal / plus Hydraglyde for As

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm Voluma XC for Chin Augmentation

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM IMPLANTABLE NEUROSTIMULATOR FOR URINARY CONTROL

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT FOR CHILDREN

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR