Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)

FDA 510(k)

FDA Class 2 ·Orthopedic

KITAZATO IUI CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

2-in-1 Abdominal Muscle Training & Back Pain Relief System

FDA 510(k)

FDA Class 2 ·Neurology

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRYOTOP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ZOMED 30F ELECTROSURGICAL PROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MYOGUIDE SYSTEM MODEL 8008

FDA 510(k)

FDA Class 2 ·Anesthesiology

ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM

Handheld VitalSigns Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

FDA 510(k)

FDA Class 2 ·General Hospital

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)

FDA Class 2 ·Anesthesiology

Diode Laser Therapy Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fingertip Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TIDAL WAVE SP MODEL 710/715 AND 715

FDA 510(k)

FDA Class 2 ·Cardiovascular