SMITH & NEPHEW, INC. REVISION KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SMITH & NEPHEW MODULAR FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0

FDA 510(k)

FDA Class 2 ·Neurology

COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

HANAROSTENT LowAx Colon/Rectum (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS

FDA 510(k)

FDA Class 2 ·Neurology

EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IQ LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPOTCHEM II LDH TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LDH-INT TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COLORIMETRIC LDH REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LACTATE DEHYDROGENASE (LDH-L)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LDH REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLINISTAT LDH REAGENT TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LACTATE DEHYDROGENASE (LDH) REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HYCEL LDH-INT TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COLORIMETRIC DETERMINATION (LDH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARESIDE LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry