535 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA.
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·ABBOTT REALTIME HBV ASSAY
Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
FDA Pre-Market Approval
FDA Class 3
·Vysis CLL FISH Probe Kit
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Plexa ProMRI DF- S DX 65/15/17; IIivia 7 DR-T; Inrica 5 DTR-T
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa Deep Brain Stimulation Therapy System
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Activa®, Percept and SenSight Deep Brain Stimulation Therapy System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision Spinal Cord Stimulator (SCS) Systems
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LADARVISION 4000 EXCIMER LASER SYSTEM
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·ACTIVA PC IMPLANTABLE NEUROSTIMULATION SYSTEM
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense