Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm Volbella XC

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Collamer UV Absorbing Posterior Chamber Three and One Piece Foldable Intraocular LEns

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EnVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL), Model MX60E Lens Holder

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis for use at One or Two Levels

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH AAA ENDOCASCULAR GRAFT WITH H + L-B ONE-SHOT INTRODUCTION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Revanesse® Lips+

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·FEMCAP BARRIER CONTRACEPTIVE

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·LEA'S SHIELD BARRIER CONTRACEPTIVE

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard Stool DNA-Based Colorectal Cancer Screening Test

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Silk

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve