2,051 results · 20ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·SALINE-FILLED BREAST IMPLANTS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens and Delivery Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·ALGOVITA SPINAL CORD STIMULATION SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Voluma XC, Juvéderm VollureTM XC, Juvéderm Volbella XC

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·LOTRAFILCON A & B SOFT CONTACT LENSES

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Injectable Gel Implants

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·Resure Sealant

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·ReSure Sealant

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·ReSure Sealant