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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM ¿ MBT REVISION TIBIAL TRAYS

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

FDA Pre-Market Approval

FDA Class 3 ·LCS® Total Knee System - MBT Thick Tray

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval

FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Heart System

EDP-20 PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

MIKROS, MIKROS VS-1, PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

NEOS VS-1, PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT STRIP BONE GRAFT MATRIX

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·INOUE-BALLOON Catheter

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT MATRIX

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·INOUE BALLOON CATHETER

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·INOUE BALLOON CATHETER

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT MATRIX