GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRABECULAR METAL VERTEBRAL BODY REPLACEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

APC FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

ZENITH TOTAL ETCH 10% PHOSPHORIC ACID

FDA 510(k)

FDA Class 2 ·Dental

BOND-ON 4

FDA 510(k)

FDA Class 2 ·Dental

MSI-CAL 16

FDA 510(k)

FDA Class 2 ·Hematology

OR TABLE/MAGNETOM OPEN VIVA SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING

FDA 510(k)

FDA Class 2 ·Orthopedic

ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSTEONICS N2/VAC PACKAGING PROCESS

FDA 510(k)

FDA Class 2 ·Orthopedic

ENCORE SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

DATASCOPE MULTINEX II

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRIATHLON TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CORE Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

SteriTite Container System with MediTray Products

FDA 510(k)

FDA Class 2 ·General Hospital

RF CARD TEST

FDA 510(k)

FDA Class 2 ·Immunology

MICRO DYNAMIC MESH

FDA 510(k)

FDA Class 2 ·Dental

ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MARDX LYME DISEASE IFA (IGM) TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology