BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

FDA 510(k)

FDA Class 2 ·Neurology

SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A

FDA 510(k)

FDA Class 2 ·Radiology

IMAGE-IGE

FDA 510(k)

FDA Class 2 ·Immunology

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Triathlon Total Knee System-Additional Components

FDA 510(k)

FDA Class 2 ·Orthopedic

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

FDA 510(k)

FDA Class 2 ·Orthopedic

Restoration® Modular Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

Global Modular Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components

FDA 510(k)

FDA Class 2 ·Orthopedic

Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

LATERA Absorbable Nasal Implant System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Triathlon PKR System

FDA 510(k)

FDA Class 2 ·Orthopedic

Trident II Acetabular System

FDA 510(k)

FDA Class 2 ·Orthopedic

Trident® II Acetabular System

FDA 510(k)

FDA Class 2 ·Orthopedic

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

FDA 510(k)

FDA Class 2 ·Orthopedic

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS

Osteon Precision Milled Suprastructure

FDA 510(k)

FDA Class 2 ·Dental

Osteon Precision Milled Suprastructure

FDA 510(k)

FDA Class 2 ·Dental

ClearPath Disposable Introducer

FDA 510(k)

FDA Class 2 ·Neurology

GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology