STROPP (Single Tunnel Repair of Plantar Plate)

FDA 510(k)

FDA Class 2 ·Orthopedic

POINT OF USE II SHARPS-A-GATOR

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES

FDA 510(k)

FDA Class 2 ·Orthopedic

Family of Steam sterilizers B17 B22 Series

FDA 510(k)

FDA Class 2 ·General Hospital

CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)

FDA 510(k)

FDA Class 2 ·Radiology

ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KF-E SERIES OF HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

TELERADIOLOGY DEVICE & COMPONENT OF PACS COMPONENT

FDA 510(k)

FDA Class 2 ·Radiology

CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION

FDA 510(k)

FDA Class 2 ·Radiology

DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF

FDA 510(k)

FDA Class 2 ·Microbiology

QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology