VARIAX 2 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ALTA INTRAMEDULLARY ROD SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI XFIX DFS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO OMEGA 21 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AZUL PERSONAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVANCED AUTOMATIC KV

FDA 510(k)

FDA Class 2 ·Radiology

POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AVS AS PEEK Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

ACE T4 REAGENT T4 CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DURACON CONVERSION METAL BACKED PATELLA

FDA 510(k)

FDA Class 2 ·Orthopedic

SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BERICHROM HEPARIN

FDA 510(k)

FDA Class 2 ·Hematology

LINK DYNAMIC STAPLE

FDA 510(k)

FDA Class 2 ·Orthopedic

SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BICARBONATE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CANTATA EMG/EVOKED RESPONSE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology