Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENTS

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR FORM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

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

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat, Absorable Collagen, Hemostatic Sponge Collastat, Absorbable Collagen Hemostatic Agent, Microfibrillar Form

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ACRYLIC MONOFOCAL IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 1-PIECE IOL, TECNIS 1-PIECE OPTIBLUE IOL, PRELOADED TECNIS 1-PIECE IOL, PRELOADED TECNIS 1-PIECE OPTIBLUE IOL, PR

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template Intergra, Ominigraft Dermal Regenerati

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Hilistat, Helitene, Absorbable Collagen Hemostatic Agents

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OsteoGen Impantable Bone Growth Stimulators

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)