800 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·VISX EXCIMER LASER SYSTEM MODELS B AND C
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·BRIO NEUROSTIMULATION SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Biologic Material, Dental
FDA Pre-Market Approval
FDA Class 3
·Straumann Emdogain
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Perceval Sutureless Heart Valve, Perceval PLUS Sutureless Heart Valve
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME REVEL SYSTEM
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 630G SYSTEM WITH SMARTGUARD
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 530G SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·IPRO2 CGM SYSTEM WITH ENLITE SENSOR
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REFLUX MANAGEMENT SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·iSert Preloaded IOL System, IPure Preloaded IOL System
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME REVEL SYSTEM
System, Rf/Microwave Hyperthermia, Cancer Treatment
FDA Pre-Market Approval
FDA Class 3
·BSD-500 HYPERTHERMIA SYSTEM
System, Laser, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·COHERENT OPAL PHOTOACTIVATOR
Cancer-Related Germline Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·BRACANALYSIS CDX