Axonpen, Axonmonitor, Axonbox, Tablet

FDA 510(k)

FDA Class 2 ·Neurology

FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA

FDA 510(k)

FDA Class 2 ·Cardiovascular

Q-LUX PLASMA 100 LIGHT CURE UNIT

FDA 510(k)

FDA Class 2 ·Dental

ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH

FDA 510(k)

FDA Class 2 ·Dental

ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)

FDA 510(k)

FDA Class 2 ·Dental

TAIMedImg DeepMets

FDA 510(k)

FDA Class 2 ·Radiology

Neuroblade System

FDA 510(k)

FDA Class 2 ·Neurology

ClearPath Disposable Introducer

FDA 510(k)

FDA Class 2 ·Neurology

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

SavDenTM MTA Root Canal Filling Materials

FDA 510(k)

FDA Class 2 ·Dental

SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES

FDA 510(k)

FDA Class 2 ·Radiology

SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES

FDA 510(k)

FDA Class 2 ·Radiology

WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US

FDA 510(k)

FDA Class 2 ·Cardiovascular

M-50 SERIES SPO2 SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

WRIST PULSE OXIMETER MD300W

FDA 510(k)

FDA Class 2 ·Cardiovascular

I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2

FDA 510(k)

FDA Class 2 ·Ophthalmic

DYNA IMPLANT DESIGN

FDA 510(k)

FDA Class 2 ·Dental

Copioumed Chemotherapy Isolation Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery