10,000 results
·
49ms
·
Sources: EU EUDAMED, US FDA
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Praxis Extended RAS Panel
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NeuroPace® RNS® System
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MemoryShape Breast Implants
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·CORDIS S.M.A.R.T.AND S.M.A.R.T.CONTROL VASCULAR STENT SYSTEM
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA Implant System
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·SCULPTRA
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·SUPERA PERIPHERAL STENT SYSTEM
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Minerva Genesys HTA Endometrial Ablation System
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA Pre-Market Approval
FDA Class 3
·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS
Bronchial Thermoplasty System
FDA Pre-Market Approval
FDA Class 3
·ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ELECSYS TOTAL PSA IMMUNOASSAY
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Sientra OPUS Silicone Gel Breast Implants
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Biosense Webster Cables