1,103 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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
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
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSURE SP,Z,Z NOVUS,SP NOVUS
Catheter, Percutaneous, Long Term, Intraspinal
FDA Pre-Market Approval
FDA Class 3
·PORT-A-CATH EPIDURAL/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·SELECTSECURE LEAD
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSURE EPICARDIAL PACING LEAD
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEM FAMILIES
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·Sprint Quattro Lead