Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520

URETEROSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGICAL APPAREL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EQUINOX CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARTHROSCOPES

FDA 510(k)

FDA Class 2 ·Orthopedic

Technoweb Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GYNECOLOGICAL LAPAROSCOPES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CYSTOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5

FDA 510(k)

FDA Class 2 ·Ophthalmic

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

FDA 510(k)

FDA Class 2 ·Neurology

TRAQinform IQ

FDA 510(k)

FDA Class 2 ·Radiology

DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4

FDA 510(k)

FDA Class 2 ·Dental

CUSTOM CRANIOFACIAL IMPLANT (CCI)

FDA 510(k)

FDA Class 2 ·Neurology

KELYNIAM CUSTOM SKULL IMPLANT (CSI)

FDA 510(k)

FDA Class 2 ·Neurology

HYSTEROSCOPES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GALAXY POWERED WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

ENT ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODEL 4222 AMBULATORY ECG MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

GENERAL SURGICAL LAPAROSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology