Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Oxford Partial Knee System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·The Oxford Partial Knee System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity, Assurity, Endurity Core, Zenus, Zenex

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TM) LARGE GRANULAR (LG)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·PERI-OSS

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·ALVEOFORM TM BIOGRAFT

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

FDA Pre-Market Approval

FDA Class 3 ·Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATORS, SPF-PLUS-MINI SPINAL FUSION STIMULATORS

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6