300 results · 19ms · Sources: EU EUDAMED, US FDA

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)