2,467 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·PLATINIUM CRT-D 1711/1741
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT
Applicator, Hyperthermia, Interstitial
FDA Pre-Market Approval
FDA Class 3
·VOL. HYPERTHERMIA TREATMENT SYSTEM MODAL VH8500
Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
FDA Pre-Market Approval
FDA Class 3
·PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBsAg
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·Reflection Ceramic Hip System
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ORCHESTRA PLUS PROGRAMMER & ELAVIEW 2.02 UG1 PROGRAMMING SOFTWARE
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·R3 DELTA CERAMIC ACETABULAR SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·INFUSE Bone Graft
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·ORCHESTRA PROGRAMMER
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·R3 Delta Ceramic Acetabular System