BraidE Embolization Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

TIDI BRAND STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

HANAROSTENT Benefit Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Dental High-speed Handpiece and Accessories

FDA 510(k)

FDA Class 1 ·Dental

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Drivewire 24 Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Dental Low-speed Handpieces and Accessories

FDA 510(k)

FDA Class 1 ·Dental

HANAROSTENT LowAx Colon/Rectum (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LANCER L-INA ANTI-IGA

FDA 510(k)

FDA Class 2 ·Immunology

LANCER L-INA ANTI-C3

FDA 510(k)

FDA Class 2 ·Immunology

LANCER L-INA ANTI-IGM

FDA 510(k)

FDA Class 2 ·Immunology

LANCER L-INA ANTI-IGG

FDA 510(k)

FDA Class 2 ·Immunology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·IN A WINK CLEANING SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·IN A WINK CLEANING SOLUTION

2 Face / Face Evolution

FDA 510(k)

FDA Class 2 ·Neurology