11 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·Superion Indirect Decompression System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·PROGEL PLEURAL AIR LEAK SEALANT WITH RECOMBINANT HUMAN ALBUMIN
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·3F AORTIC BIOPROSTHESIS
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SYNCHROMED II IMPLANTABLE INFUSION SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME INSULIN (MODEL MMT-522/MMT-522K/MMT-722/MMT-722K/MMT-523/MMT-523K/MMT-723/MMT-723K)
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HIRESOLUTION BIONIC EAR SYSTEM
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3