SECURLINE FRANSEENE NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TIDI BRAND STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

HANAROSTENT Benefit Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ERBOKRYO CA CRYOSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION

FDA 510(k)

FDA Class 2 ·Orthopedic

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

SMITH & NEPHEW PLATFORM HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Drivewire 24 Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS

FDA 510(k)

FDA Class 2 ·Orthopedic

SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION

FDA 510(k)

FDA Class 2 ·Orthopedic

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JOURNEY UNICONDYLAR TIBIAL BASEPLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

NEURONET

FDA 510(k)

FDA Class 2 ·Neurology

HANAROSTENT Trachea/Bronchium (CCC)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HANAROSTENT FASTTM Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMITH & NEPHEW PATELLO-FEMORAL IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic