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

NEXA™ NPWT System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEXA Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)

FDA 510(k)

FDA Class 2 ·Dental

Y-MIC

FDA 510(k)

FDA Class 2 ·Dental

AW-100

FDA 510(k)

FDA Class 2 ·Dental

ARTIFICIAL SCLERAL SHELL

FDA 510(k)

FDA Class 2 ·Ophthalmic

CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Adhesive Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat