1,099 results · 23ms · Sources: EU EUDAMED, US FDA

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS AUDITORY BRAINSTEM IMPLANT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Carotid WALLSTENT Monorail Endoprosthesis

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·SAPIEN 3 Ultra Transcatheter Heart Valve

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set

Device, Hemostasis, Vascular

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

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ VR Leadless Pacemaker: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ DR Leadless Pacemaker: Aveir™ Leadle

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA DR IPG,ADVISA DR MRI IPG

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·SmartAblate System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus-

Ablation Catheter, Renal Denervation

FDA Pre-Market Approval
FDA Class 3 ·Symplicity Spyral™ Renal Denervation System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 530G INSULIN PUMP

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clarisert Preloaded IOL System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK ULTRA RX AND OTW CORONARY STENT SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·BOND ORACLE HER2 IHC SYSTEM