300 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MARQUIS/MAXIMO/INTRINSIC ICDS
Gonococcal Antibody Tests
FDA Pre-Market Approval
FDA Class 3
·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
Stimulator, Autonomic Nerve, Implanted (Depression)
FDA Pre-Market Approval
FDA Class 3
·VNS THERAPY SYSTEM PULSE GENERATORS
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·STELID II BFT/BJF/STELIX BR/STELIX II BRF
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·STELID II BFT/BJF/STELIX BR/STELIX II BRF
Cap, Cooling (Infants)
FDA Pre-Market Approval
FDA Class 3
·OLYMPIC COOL-CAP SYSTEM
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·IMMULITE 2500 AFP, MODEL L5KAP
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscoelastic System, and DISCOVISC Ophthalmic Viscosurgic
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SM-1, CR-1, & GR-1 IOLS
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT/DUOVISC Ophthalmic Viscoelastic System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS B-13F (P-10) & B-1H (P-11)
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·IOL LENS MODEL GR1A
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT, DISCOCISC Ophthalmic Viscosurgical Device
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LADARVISION 4000 EXCIMER LASER SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·PMMA ANTERIOR CHAMBER IOLS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·LASER WELDING REVERSE HAPTIC ASPECT RATIO
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·PMMA INTRAOCULAR LENSES (IOLS)