Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2030, HX2035

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT

FDA Pre-Market Approval

PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM

FDA Pre-Market Approval

PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR XL 8 & 10F PVS SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

Tissue Adhesive Internal Use

FDA Pre-Market Approval

FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Tissue Adhesive Internal Use

FDA Pre-Market Approval

FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Pulse Generator, External Pacemaker, Dual Chamber

FDA Pre-Market Approval

FDA Class 2 ·REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS

Salivary Estriol Test

FDA Pre-Market Approval

FDA Class 3 ·SALEST TM SYSTEM

Pulse Generator, External Pacemaker, Dual Chamber

FDA Pre-Market Approval

FDA Class 2 ·RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS

Tissue Adhesive Internal Use

FDA Pre-Market Approval

FDA Class 3 ·LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Pulse Generator, External Pacemaker, Dual Chamber

FDA Pre-Market Approval

FDA Class 2 ·RELIATY / MODEL 3145 PACING SYSTEM

FDA Pre-Market Approval

PERCLOSE PROSTAR XL 8 & 10 FRENCH PVS SYSTEM

FDA Pre-Market Approval

PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL