Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

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

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM & SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

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

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

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

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER® Smart System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OsteoGen Implantable Bone Growth Stimulators

Catheter, Balloon, Transcervical

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 Sponge and Collaslat Absorbable Collagen Hemostatic - Microfibrillar Form

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·OSTEOSTIM(R)

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER® Smart System

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF(R) IMPLANTABLE SPINAL FUSION STIMULATOR

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

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

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA ARTIFICIAL SKIN & MESHED DERMAL REGENERATION TEMPLATE,INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX, Integra Me