BACTON(TM), AUTO-APO A-1 REAGENT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER

FDA 510(k)

FDA Class 2 ·Neurology

Physiotrace

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Endoform Reconstructive Template

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZEPTO Precision Capsulotomy System

FDA 510(k)

FDA Class 2 ·Ophthalmic

RRIANGLE KNIFE

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)

FDA 510(k)

FDA Class 2 ·General Hospital

Europa Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Austin Miller Large External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

IO Expandable Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

FDA 510(k)

FDA Class 2 ·Orthopedic

Foundation Dermal Regeneration Scaffold (DRS) Solo

FDA 510(k)

FDA Unclassified ·Unknown

LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

NEUROMED MODEL 1992 LS LAMITRODE LEAD

FDA 510(k)

FDA Class 2 ·Neurology

Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRASAFE DENTAL INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Intelli-Ox

FDA 510(k)

FDA Class 1 ·Anesthesiology