Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601

FDA 510(k)

FDA Class 2 ·Radiology

Dental Cone-beam Computed Tomography (FinScan F350)

FDA 510(k)

FDA Class 2 ·Radiology

Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CRE Pulmonary Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Hygenix

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

All-in-One Health Monitor, PC-303

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRE RX Biliary Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

FDA 510(k)

FDA Class 2 ·General Hospital

Safe Secure Sterilization Pouches and Rolls

FDA 510(k)

FDA Class 2 ·General Hospital

Handheld Pulse Oximeter, Model SP-20

FDA 510(k)

FDA Class 2 ·Cardiovascular

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

FDA 510(k)

FDA Class 2 ·Dental

MANTIS Clip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CO2 Laser Machine, Model: BW-203B

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser Machine, Model Number: BM-100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Transcutaneous Electrical Nerve Stimulator (K6106)

FDA 510(k)

FDA Class 2 ·Neurology

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

FDA 510(k)

FDA Class 2 ·Radiology

MAGLUMI 2000 HCG/ß-HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry