Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·comfilcon A

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, AND ZEPHYR PACEMAKERS

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI ORTHOGEN(R)/OSTEOGEN(TM) IMPLANTABLE BONE GROWTH STIMULATOR

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Arista AH Absorbable Hemostatic Particles

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 1256D META MV CARDIAC PULSE GENERATOR

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·AUGMENT BONE GRAFT

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REGENCY PACEMAKERS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM FAMILY OF NEUROSTIMULATION LEADS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS

Prosthesis, Posterior Spinal Elements

FDA Pre-Market Approval

FDA Class 3 ·TOPS™ System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF CRT-D AND QUICKSITE & QUICKFLEX LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDA-MV PACING SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC-58NBM & PC-58NBZ IOLS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY PACEMAKERS