9,107 results · 25ms · Sources: EU EUDAMED, US FDA

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ACCULINK CAROTID STENT SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·ORBERA INTRAGASTRIC BALLOON SYSTEM

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS TOTAL PSA

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SCULPTRA AND SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE CARDIOFORM Septal Occulder

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE (+) Lidocaine Dermal Filler

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Orthovisc

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·INFUSE BONE GRAFT

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·BRYAN CERVICAL DISC

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectris® Spinal Cord St

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·INFUSE BONE GRAFT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM 13

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER LA-15 System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Onyx Zotarolimus Eluting Coronary Stent System

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL/PASSIVE PLUS/AV PLUS DX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEMA FAMILIES/C & T SERIES DEVICES

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·INSYNC FAMILIES OF ICD & CONCERTO ICD