Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·FILL/FLUSH EXTRACTION SYSTEM FOR ACRYSOF, AND ACRYSOF RESTOR INTRAOCULAR LENSES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTOREPRIME NEUROSTIMULATOR, PRIMEADVANCED NEUROSTIMULATOR, ITREL 4 PROGRAMMABLE NEUROSTIMULATOR FOR SPINAL CORD

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE AND COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgergy

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Laser Angle Measurement Tool for Open and Close Leaflet Angles Measurement

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Toric (comfilcon A) soft (hydrophilic) Contact Lenses for Extended Wear

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc - C and prodisc - C Nova (Indicated for Single Level Use)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR