Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·Guardian System

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL ABSORBABLE HEMOSTAT

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL Absorbable Hemostats

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·iCast Covered Stent System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System.

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat and Helitene Absorbable Collagen Hemostatic Agents

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA (1% Sodium Hyaluronate)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT

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

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II

Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval

FDA Class 3 ·SCOLITRON(TM) STIMULATOR

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

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

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators