IntelliSpace Portal Platform

FDA 510(k)

FDA Class 2 ·Radiology

FRESENIUS HAEMODIALYSIS ;MACHINE A1008

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Infrascanner

FDA 510(k)

FDA Class 2 ·Ophthalmic

IGI-SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

HemoScreen Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ESOP S/C FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CABOCHON SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATLAS III ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

FDA 510(k)

FDA Class 2 ·General Hospital

Warmer, Blood, Non-Electromagnetic Radiation

FDA classification

FDA Class 2 ·Warmer, Blood, Non-Electromagnetic Radiation

Needle, Conduction, Anesthesia, Reprocessed

FDA classification

FDA Class 2 ·Needle, Conduction, Anesthesia, Reprocessed

Ovarian Adnexal Mass Assessment Score Test System

FDA classification

FDA Class 2 ·Ovarian Adnexal Mass Assessment Score Test System

UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED

FDA 510(k)

FDA Class 2 ·Orthopedic

REPLICA TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP

FDA 510(k)

FDA Class 2 ·Orthopedic

APR II FEMORAL COMPONENT (VARIOUS)

FDA 510(k)

FDA Class 2 ·Orthopedic

TITANIUM GDLH POSTERIOR SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ECONOSTAND

FDA 510(k)

FDA Class 2 ·Physical Medicine