1,620 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·INTERCEED ABSORBABLE ADHESION BARRIER
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·R3 Delta Ceramic Acetabular System
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Bellafill Dermal Filler
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG)
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·S.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate 3 Left Ventricular Assist System
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·prodisc® C
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·prodisc® L
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·TRIFECTA VALVE
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL Cochlear Implant System
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·BIOCOR/EPIC VALVE
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Restylane Kysse
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HPV HR
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HPV 16/18
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER MUSCULAR VSD OCCLUDER
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·MINERVA ENDOMETRIAL ABLATION SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CareLink SmartSync Percepta Serena Solara Application; Percepta, Serena, Solara Quard CRT-P MRI SureScan.
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700/AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)