502 results · 20ms · Sources: EU EUDAMED, US FDA

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoSense

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Collamer Intraocular Lens (CIOL)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Lens, Intraocular, Phakic

FDA Pre-Market Approval
FDA Class 3 ·Visian Implantable Collamer Lens (ICL)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Vascular Closure System (VCS)-VASCADE 5F Vascular Closure System, VASCADE 6/7F Vascular Closure System, VASCADE MVP Veno

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Implantable Cardioverter Defibrillator ICDs

Implant, Cochlear

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ORSIRO Sirolimus Eluting Coronary Stent System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·Osteonics ABC/Trident System

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

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

FDA Pre-Market Approval
FDA Class 3 ·Avant™ HF, Neutrino™ NxT HF, Gallant™ HF, Entrant™ HF

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM

Implant, Cochlear

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Avant™ VR, Neutrino™ NxT VR, Gallant™ VR, Entrant™ VR, Avant™ DR, Neutrino™ NxT DR, Gallant™ DR, Entrant™ DR

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY SYSTEM (MONORAIL AND OVER THE WIRE)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher