824 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum
FDA Pre-Market Approval
FDA Class 3
·AFP MID-PREGNANCY REFERENCE PREPARATION
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·Rotlex IOLA MFD
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)
Lithotripter, Shockwave (For Treating Gallbladder Stones)
FDA Pre-Market Approval
FDA Class 3
·MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL CI System
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL Cochlear Implant
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL COMBI 40+
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL CONCERT IMPLANT
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL Cochlear Implants
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL COCHLEAR IMPLANT SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL Cochlear Implant System
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
FDA Pre-Market Approval
FDA Class 3
·MED-EL COCHLEAR IMPLANT SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL Cochlear Implant System