4,919 results · 21ms · Sources: EU EUDAMED, US FDA

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/650/800/900 IPGS/ENPULSE/SIGMA/MEDTRONIC 350 SERIES/AT500/ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DURASPHERE INJECTABLE BULKING AGENT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX MRI SURESCAN LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN BIPOLAR OTW/OTW/CS LEAD

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·Rotablator™and ROTAPRO™ Rotational Atherectomy System, RotaWire™ Guidewire and wireClip™ Torquer, ROTAWIRE™ Drive Guidew

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·LEAD ASSEMBLY

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Cobas HBV

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·BOND Oracle HER2 IHC System

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER MULTI-FENESTRATED SEPTAL OCCULDER (CRIBRIFORM)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, RELIA IPG

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MOSIAC PORCINE BIOPROSTHESIS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS CI500 SERIES COCHLEAR IMPLANT SYSTEM

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSure Sense Lead 4074, 4574; CapSure SP Novus Lead 4092, 4592

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Aortic Root Bioprosthesis

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DURASPHERE INJECTABLE BULKING AGENT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS

Implant, Cochlear

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

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·INSYNC CRT-P/INSYNC III CRT-P

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESES