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

Freedom Spinal Cord Stimulator System

FDA 510(k)

FDA Class 2 ·Neurology

Osteon Precision Milled Suprastructure

FDA 510(k)

FDA Class 2 ·Dental

Osteon Precision Milled Suprastructure

FDA 510(k)

FDA Class 2 ·Dental

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M

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

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

RABBIT ANTIBODY TO DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CBR-DIGOXIN ANTISERUM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Keymill

FDA 510(k)

FDA Class 2 ·Dental

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB-M 7180/ HAVAB-M EIA 9843/IMX HAVAB-M 2263