Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ProCol Vascular Bioprosthesis

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Device Command Library (DCL), CareLine Express

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Instrument Command Library (ICL), Device Command Library (DCL)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI (CROFILCON A) EXTENDED WEAR SOFT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MyCareLink Patient Monitor, Device Command Library (DCL) , Device Data Management Application (DDMA) CareLink Express, C

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R) SP PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX STEROID ELUTING LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX TM MODEL 5072 LEAD