3,491 results · 19ms · Sources: EU EUDAMED, US FDA

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