Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II+/Avant/Neutrino NxT/Gallant/Ent

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VITRAX SODIUM HYALURONATE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CM(TM) LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·X-70 SOFT CONTACT LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV/ABSORBING POSTERIOR CHAMBER IOL MODEL UPB330FS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL UPB350NS POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS U260,U360,U360N,U365,U370,&UP383 LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)