Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750,PARADYM DR8750,ISOLINE 2CT-ISOLINE 2CR

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR HIP SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750, PARADYM DR 8750, PARADYM RF CRT-D

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Prestige LP (R) Cervical Disc

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR HIP SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II BTF/BJF STEROID COLLAR

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM DR/VR

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM