9,662 results
·
40ms
·
Sources: EU EUDAMED, US FDA
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE...
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Avalus Ultra Bioprosthesis
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT, DUOVISC,DISCOVISC
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
Device, Impotence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·Titan Inflatable Penile Prosthesis
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYSHAPE BREAST IMPLANTS
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYSHAPE BREAST IMPLANTS
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace and Sentimag Magnetic Localization System
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA REAGENT ON THE ACCESS IMMUNOASSAY SYSTEM
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN Left Atrial Appendage (LAA) Closure Te
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Mentor MemoryShape Silicone Gel-Filled Breast Implants
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·ACS CORONARY DILATATION CATHETERS (INDICATION)
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MiniMed 630G Pump
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Implantable System for Remodulin (ISR)