3,217 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx (F1CDx)
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·NOVOSTE BETA-CATH SYSTEM
Biologic Material, Dental
FDA Pre-Market Approval
FDA Class 3
·Staumann Emdogain
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·ELEVESS (AKA COSMETIC TISSUE AUGMENTATION PRODUCT)
Implanted Fecal Incontinence Device
FDA Pre-Market Approval
FDA Class 3
·ACTICON NEOSPHINCTER
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HUMAN PAPILLOMA VIRUS (HPV)
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·ReShape Integrated Dual Balloon System
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·CODMAN 3000 IMPLANTABLE DRUG DELIVERY SYSTEM
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
Stent, Iliac Vein
FDA Pre-Market Approval
FDA Class 3
·VICI VENOUS STENT System
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Selenia Dimensions 3D System.
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 URINARY CONTROL SYSTEM
Reherniation Reduction Device
FDA Pre-Market Approval
FDA Class 3
·Barricaid® Annular Closure Device
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THIN PREP PROCESSORS
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP 2000 SYSTEM
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CARDIOMEMS HF SYSTEM
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·ON-X PROSTHETIC HEART VALVE
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS Ambicor Inflatable Penile Prosthesis