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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

HANAROSTENT LowAx Colon/Rectum (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

ARCHITECT BNP ASSAY, MODEL 8K28

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRIAGE BNP TEST, MODEL 98000XR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ST AIA-PACK BNP Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Sublime Radial Access 018 RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLAID OCULAR ELECTROPHYSIOLOGY DEVICE

FDA 510(k)

FDA Class 2 ·Neurology

ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS

FDA 510(k)

FDA Class 2 ·Dental

WARSAW ORTHOPEDIC BONE PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

OBELISC VERTEBRAL BODY REPLACEMENT DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

IVIEW

FDA 510(k)

FDA Class 2 ·Radiology