System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·QCELLUS LASER

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR AND EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE IMPLANTABLE PUMP

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·AngelMed Guardian® System

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, Integra Omnigraft Dermal Regeneration

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERCEED™ Absorbable Adhesion Barrier

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA (ARTIFICIAL SKIN)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE, COLLATAPE, COLLAPLUG ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat/INSTAT Absorbable Collagen Hemostatic Agent

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact Spine Sealant System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR