10,000 results
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48ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 530G SYSTEM
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System (URINARY)
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·BRIO NEUROSTIMULATION SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CapSureFix MRI Lead 5086MRI
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·Monovisc
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·LIMULUS AMEBOCYTE LYSATE BACTERIA TEST
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·SOLESTA
Cancer-Related Germline Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·BRACANALYSIS CDX
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·COAPTITE INJECTABLE IMPLANT
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM THERAPY SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG QUALITATIVE/HBSAG QUALITATIVE CONFIRMATORY
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE SYSTEMS)
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·FINELINE II PACE/SENSE LEAD
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·LIBERTE CORONARY STENT SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE EXCLUDER AAA ENDOPROSTHESIS