PRECI-JET 50

FDA 510(k)

FDA Class 2 ·General Hospital

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE

FDA 510(k)

FDA Class 2 ·Physical Medicine

SKIFA, PLASTIC DISPOSABLE SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

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

V5med Lung AI

FDA 510(k)

FDA Class 2 ·Radiology

ORTHOCOR KNEE SYSTEM BASIC

FDA 510(k)

FDA Class 2 ·Physical Medicine

HANAROSTENT LowAx Colon/Rectum (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEGACY3 6MM LENGTH IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VENOTRAIN CURAFLOW

FDA 510(k)

FDA Class 2 ·General Hospital

STERILIZATION WRAP-STERISHEET

FDA 510(k)

FDA Class 2 ·General Hospital

TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)

FDA 510(k)

FDA Class 2 ·Microbiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·IMX(R) HAVAB

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX PSA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·IMX(R) HAVAB