Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·X-STOP INTERSPINOUS SPACER SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Lenstec Softec HD aspheric posterior chamber intraocular lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (IOLS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VANTAGE & VANTAGE THIN (TETRAFILCON A) CONTACT LEN

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTLENS66 TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VANTAGE & VANTAGE THIN (TETRAFILCON A) CONTACT LEN

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL HSM65 UV ABSORBING PMMA ANTERIOR CHAMBER LENS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, LED VENTRICULAR PACING LEAD

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER IOL

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS