10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Gonococcal Antibody Tests
FDA Pre-Market Approval
FDA Class 3
·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Cerene Cryotherapy Device (Model Number FGS-7000)
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ICS 3000 IMPLANT CONTROL SYSTEM
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·PHYLAX AV ICD SYSTEM
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·KRONOS LV-T CRT-D
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THXID-BRAF KIT
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Aptima HBV Quant Assay