10,000 results
·
61ms
·
Sources: EU EUDAMED, US FDA
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CardioMEMS HF System
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MemoryGel Breast Implant
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 ARTIFICIAL URINARY SPHINCTER
Dorsal Root Ganglion Stimulator For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Axium Neurostimulator System
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·AXSYM TOTAL PSA
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR UP TO 30 NIGHTS CONTINUOUS WEAR
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·INTERCEED ABSORBABLE ADHESION BARRIER
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, AND ZEPHYR PACEMAKERS
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·ANIKA VISC
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Single-Piece PMMA Anterior Chamber IOLs
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SMARTTOUCH SF Catheter
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise DBS System
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HiResolution Bionic Ear System
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·DURALOC OPTION CERAMIC HIP SYSTEM
Stimulator, Invasive Bone Growth
FDA Pre-Market Approval
FDA Class 3
·SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Medtronic Revo MRI SureScan IPG and Pacing System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TALENT THORACIC STENT GRAFT SYSTEM