Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere, Biofinity Toric

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense

Tissue Adhesive For Internal Use

FDA Pre-Market Approval

FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Oxford Partial Knee System

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL(TM)

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL(TM)

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL(TM)

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL(R) OSSMOTIC CERVICAL DILATOR

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·DILAPAN(TM)

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·DILAPAN-S CERVICAL DILATOR

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL(R) OSSMOTIC CERVICAL DILATOR

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL OSMOTIC CERVICAL DILATOR

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL OSMOTIC CERVICAL DILATOR

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM