1,138 results · 28ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STAAR SURGICAL UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SILICONE UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STAAR SURGICAL SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·EC-5000 EXCIMER LASER SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA classification
FDA Class 3 ·Pacemaker/Icd/Crt Non-Implanted Components

Gonococcal Antibody Tests

FDA Pre-Market Approval
FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA classification
FDA Class 3 ·Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)