1,179 results · 19ms · Sources: EU EUDAMED, US FDA

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent – Fibrillar Form

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart, Smart Mini, and Lite Systems

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Dural Sealant System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·EUFLEXXA (1% SODIUM HYALURONATE)

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·Integra Dermal Regeneration Template

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EBI BONE HEALING SYSTEM(R)

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

Device, Dermal Replacement

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery

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

FDA Pre-Market Approval
FDA Class 3 ·Trident Alumina Insert

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

FDA Pre-Market Approval
FDA Class 3 ·Trident Ceramic System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·INTERCEED ABSORBABLE ADHESION BARRIER