947 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·CORDIS PRECISE NITINOL STENT
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·FLAIR ENDOVASCULAR STENT GRAFT
Implant, Hearing, Active, Middle Ear, Totally Implanted
FDA Pre-Market Approval
FDA Class 3
·ESTEEM
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure Sense MRI SureScan Lead
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·Inspire Upper Airway Stimulation Therapy
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Sentus QP Pacing Leads
Scaffold, Dissection Repair
FDA Pre-Market Approval
FDA Class 3
·Tack Endovascular System (6F)
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1 Liquid CDx)
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·XACT CAROTID STENT SYSTEM
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Longitudinal Surveillance Registry of the ACUITY Spiral Lead
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
Transcervical Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·BD Totalys SlidePrep
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HPV 16/18
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·TRIDENT CERAMIC-ON-CERAMIC ACETABULAR SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·R3 Delta Ceramic Hip System
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·LUTONIX® 035 Drug Coated Balloon PTA Catheter