Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval

FDA Class 3 ·MENTOR POLYTEF PASTE FOR INJECTION

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval

FDA Class 3 ·MENTOR POLYTEF PASTE FOR INJECTION

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM SYSTEM FOR URINARY CONTROL

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR BOWEL CONTROL

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval

FDA Class 3 ·MENTOR POLYTEF PASTE FOR INJECTION

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

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

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems