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® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™, SURGICEL® POWDER™)

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

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

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERCEED™ Absorbable Adhesion Barrier

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·GUARDIO/VESTA charger

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATORS, SPF-PLUS-MINI SPINAL FUSION STIMULATORS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK(R) BONE GROWTH STIMULATOR

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·OSTEONICS ABC/TRIDENT SYSTEMS

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

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

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER® Smart Mini

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIOMET EBI BONE HEALING SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·lntegraQ Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenera

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·Guardian® System