3,277 results · 20ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·activL Artifical Disc

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-Spheres Y-90 resin microspheres

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·C-FLEX INTRAOCULAR LENS MODEL 570C

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric the lens

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·iDesign Refractive Studio

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-SPHERES

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

FDA Pre-Market Approval
FDA Class 3 ·SLEEP SENTRY(TM)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·Prismaflex TPE2000

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·activeL Artificial Disc

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·ACTIVL ARTIFICIAL DISC

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Saluda Medical Evoke® SCS System

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·iDesign Refractive Studio

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filler

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·BELLAFILL