CILCO ANTERIOR CHAMBER LENS

FDA 510(k)

FDA Class 3 ·Ophthalmic

POWERED EYE WASH

FDA 510(k)

FDA Class 3 ·Unknown

BIO-PEN CALCULATOR

FDA 510(k)

FDA Class 3 ·Unknown

NANOLAS ND:YAG OPHTHALMIC LASER

FDA 510(k)

FDA Class 3 ·Unknown

BIO-PEN SRK II CALCULATOR

FDA 510(k)

FDA Class 3 ·Unknown

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-D & MAXIMO II CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 2490C CARELINK MONITOR 2020A CARDIOSIGHT READER

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWAR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 27901

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC (R)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biomedics Toric (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE PIECE POSTERIOR CHAMBER IOL