3,100 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Acute Coronary Syndrome Event Detector
FDA Pre-Market Approval
FDA Class 3
·AngelMed Guardian System
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension FPSA Flex Reagent Cartridge
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Lotus Edge Valve System
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·ENROUTE Transcarotid Stent System
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·ClearView 3
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·Nuvisc, Anikavisc, Ophthalin
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF IQ TORIC INTAOCULAR LENS
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD
Filler, Bone Void, Synthetic Peptide
FDA Pre-Market Approval
FDA Class 3
·AUGMENT BONE GRAFT
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER SEPTAL OCCLUDER
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·PMMA ANTERIOR CHAMBER IOLS
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·ADIANA PERMANENT CONTRACEPTION SYSTEM
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·BD Onclarity HPV Assay
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSURE EPI UNIPOLAR/BIOPOLAR LEADS