RANDOX EVIDENCE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AV-S ANAESTHESIA VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HABIB HEXABLATE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

geko W-2

FDA 510(k)

FDA Class 2 ·Physical Medicine

CAPTIA(R) RUBELLA-G

FDA 510(k)

FDA Class 2 ·Microbiology

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BEL-AIR VENTILATION TUBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dermalux Flex MD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System

FDA 510(k)

FDA Class 2 ·Orthopedic

Trackit T4 EEG Amplifier

FDA 510(k)

FDA Class 2 ·Neurology

Small Volume 0.2mL Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

SONICAID FM820, SONICAID FM830

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)

FDA 510(k)

FDA Class 2 ·Orthopedic

SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)

FDA 510(k)

FDA Class 2 ·Ophthalmic

THE KEYMED VARI-HEIGHT PATIENT COUCH

FDA 510(k)

FDA Class 2 ·General Hospital

Arc EndoCuff and Arc EndoCuff Vision

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UniPulse

FDA 510(k)

FDA Class 2 ·Cardiovascular