603 results · 21ms · Sources: EU EUDAMED, US FDA

Coronary Drug-Eluting Stent

FDA classification
FDA Class 3 ·Coronary Drug-Eluting Stent

Stent, Superficial Femoral Artery, Drug-Eluting

FDA classification
FDA Class 3 ·Stent, Superficial Femoral Artery, Drug-Eluting

Cranial Electrotherapy Stimulator To Treat Depression

FDA classification
FDA Class 3 ·Cranial Electrotherapy Stimulator To Treat Depression

Condom, Female, Animal Tissue

FDA classification
FDA Class 3 ·Condom, Female, Animal Tissue

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES

Stent, Coronary

FDA classification
FDA Class 3 ·Stent, Coronary

Alfapump System

FDA classification
FDA Class 3 ·Alfapump System

Permanent Defibrillator Electrodes

FDA classification
FDA Class 3 ·Permanent Defibrillator Electrodes

Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

FDA classification
FDA Class 3 ·Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA classification
FDA Class 3 ·Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Processor, Cervical Cytology Slide, Automated

FDA classification
FDA Class 3 ·Processor, Cervical Cytology Slide, Automated

Filler, Bone Void, Synthetic Peptide

FDA classification
FDA Class 3 ·Filler, Bone Void, Synthetic Peptide

Gases Used Within Eye To Place Pressure On Detached Retina

FDA classification
FDA Class 3 ·Gases Used Within Eye To Place Pressure On Detached Retina

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification
FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA classification
FDA Class 3 ·Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

FDA classification
FDA Class 3 ·Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA classification
FDA Class 3 ·Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions