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

AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

NOVOFINE 32G TIP

FDA 510(k)

FDA Class 2 ·General Hospital

PCA MODULAR PRIMARY/REVISION PATELLA

FDA 510(k)

FDA Class 2 ·Orthopedic

LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

VARIAX ELBOW SYSTEM LINE EXTENSION

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOKROME* HEPARIN

FDA 510(k)

FDA Class 2 ·Hematology

ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STA - VWF CONTROL [N]+[P] KIT

FDA 510(k)

FDA Class 2 ·Hematology