3,491 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·ISPAN PERFLUOROPROPANE C3F8 GAS
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX CERAMIC HIP SYSTEM
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·ANS EON C (IPG) NEUROSTIMULATION SYSTEM
Dorsal Root Ganglion Stimulator For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·EASYTRAK LEAD MODELS IS-1 4535/4536/4537/4538 CORONARY VENOUS STEROID-ELUTING SINGLE-ELECTRODE PACE/SENSE LEAD
Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
FDA Pre-Market Approval
FDA Class 3
·ASCENSION MCP
Stimulator, Invasive Bone Growth
FDA Pre-Market Approval
FDA Class 3
·Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Genus DBS System
Stent Graft, Bypass, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·DETOUR System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·SPECTRA WAVEWRITER SPINAL CORD STIMULATOR SYSTEM
Ventilator, High Frequency
FDA Pre-Market Approval
FDA Class 3
·LifePulse High Frequency Ventilator
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·EON MINI IPG NEUROSTIMULATION SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FREESTYLE NAVIGATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·HBSAG
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·VENTANA PD-L1 (SP142) Assay