3,165 results · 20ms · Sources: EU EUDAMED, US FDA

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·UROLUME ENDOURETHRAL PROSTHESIS

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

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Liver

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Complexed PSA (cPSA)

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with SmartAssist

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval
FDA Class 3 ·LUMBAR I/F CAGE SYSTEM

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Heart

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·HYDRELLE DERMAL FILLER

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QUICK LOAD

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNVISC HYLAN G-F 20

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur and Atellica IM PSA