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

Handheld VitalSigns Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

FDA 510(k)

FDA Class 2 ·General Hospital

Osteon Precision Milled Suprastructure

FDA 510(k)

FDA Class 2 ·Dental

Osteon Precision Milled Suprastructure

FDA 510(k)

FDA Class 2 ·Dental

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

FDA 510(k)

FDA Class 2 ·Radiology

OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Keymill

FDA 510(k)

FDA Class 2 ·Dental

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)

FDA Class 2 ·Anesthesiology

RABBIT ANTIBODY TO DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology