SQA-iOw Sperm Quality Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

DERMATOLOGICAL TREATMENT DEVICE FAMILY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HORIZON ANGIO CATHLAB

FDA 510(k)

FDA Class 2 ·Cardiovascular

HandX Instrument - Monopolar Spatula

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DUET SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

DELSONIC 2000

FDA 510(k)

FDA Class 2 ·Dental

SILCLEAR TUBING (MODIFICATION)

FDA 510(k)

FDA Class 2 ·General Hospital

SofWave System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AURORA SR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bladeless Trocar – Artemis Lap Cannula

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MDIFICATION TO MEDIPRIME

FDA 510(k)

FDA Class 2 ·Radiology

TOV Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Sofacia System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NOGA

FDA 510(k)

FDA Class 2 ·Cardiovascular

MUSE System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

EXTENTION SET

FDA 510(k)

FDA Class 2 ·General Hospital

TEVADAPTOR Closed Drug Reconstitution and Transfer System

FDA 510(k)

FDA Class 2 ·General Hospital

Apyx

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology