DUET SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DUET SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

MyHomeDoc

FDA 510(k)

FDA Class 2 ·Cardiovascular

HAND STC, MODEL 60MM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

N9+

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR

FDA 510(k)

FDA Class 2 ·Radiology

Trackit T4 EEG Amplifier

FDA 510(k)

FDA Class 2 ·Neurology

R-40 EEG Amplifier

FDA 510(k)

FDA Class 2 ·Neurology

Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00

FDA 510(k)

FDA Class 2 ·Neurology

NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN 100 IMPEDANCE METER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN AVALANCHE MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN MODEL 100

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN LARYNGEAL ELECTRODES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Rapid Therapy System

FDA 510(k)

FDA Class 2 ·Neurology

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic