70 results · 25ms · Sources: EU EUDAMED, US FDA

Implant, Resorbable, For Articular Osteochondral Repair

FDA Pre-Market Approval
FDA Class 3 ·Agili-C

Implant, Resorbable, For Articular Osteochondral Repair

FDA classification
FDA Class 3 ·Implant, Resorbable, For Articular Osteochondral Repair

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MYCARELINK PATIENT MONITOR, MYCARELINK READER FRU

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·(LGW, QRB) - Master Restore Spinal Cord Stimulation Systems

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MYCARELINK PATIENT MONITOR, MYCARELINK READER FIELD REPLACEMENT UNIT (FRU), MYCARELINK SMART PATIENT READER, CARELINK EN

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·OrganOx metra® System

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon catheter

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon Catheter

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·4Kscore Test

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·The 4Kscore Test

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·4Kscore Test

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon