DELTATRAC(TM) II METABOLIC MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M

FDA 510(k)

FDA Class 2 ·Immunology

MENISCUS ARROW, MODELS 531110, 531113, 531116

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,

FDA 510(k)

FDA Class 2 ·Orthopedic

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PLANMED SOPHIE & PLANNED SOPHIE CLASSIC

FDA 510(k)

FDA Class 2 ·Radiology

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

B40i Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525

FDA 510(k)

FDA Class 2 ·Orthopedic

INION BIORESTORE

FDA 510(k)

FDA Class 2 ·Dental

ORTHOPANTOMOGRAPH OP 3D

FDA 510(k)

FDA Class 2 ·Radiology

Icare HOME Tonometer

FDA 510(k)

FDA Class 2 ·Ophthalmic

ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY

FDA 510(k)

FDA Class 2 ·Radiology

PROSTYLE INTRA

FDA 510(k)

FDA Class 2 ·Dental

INION FREEDOMPIN

FDA 510(k)

FDA Class 2 ·Orthopedic

MULTICAP MULTIGAS CAPNOMETER PB252

FDA 510(k)

FDA Class 2 ·Anesthesiology

NORMOCAP 200 CAPNOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

OSCAR(TM) PB255 OXIMETER CAPNOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Nexstim Navigated Brain Therapy (NBT) System 2

FDA 510(k)

FDA Class 2 ·Neurology