GMK Sphere & GMK SpheriKA Cementless

FDA 510(k)

FDA Class 2 ·Orthopedic

TriALTIS Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

SYMPHONY OCT System

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINEART Navigation Instrument System

FDA 510(k)

FDA Class 2 ·Neurology

CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

BRILLIANT EVERGLOW

FDA 510(k)

FDA Class 2 ·Dental

SMS Cementless Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

Gynomunal

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Enbio S

FDA 510(k)

FDA Class 2 ·General Hospital

OneTouch Ultra Plus Flex Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROGAS 7650 TRANSCUTANEOUS MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Neo ADVISE software

FDA 510(k)

FDA Class 2 ·Neurology

CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems

FDA 510(k)

FDA Class 2 ·Neurology

HAMILTON-T1,HAMILTON-C1

FDA 510(k)

FDA Class 2 ·Anesthesiology

SCARLET® AC-T Secured Anterior Cervical Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

TBS iNsight (V4)

FDA 510(k)

FDA Class 2 ·Radiology

UNIVERSAL JET VENTILATOR MODEL AMS-1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

Santis Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

SYMPHONY™ OCT System

FDA 510(k)

FDA Class 2 ·Orthopedic

APTUS Wrist Spanning Plates 2.5

FDA 510(k)

FDA Class 2 ·Orthopedic