ACR LAB Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TI-6AL-7NB URTN

FDA 510(k)

FDA Class 2 ·Orthopedic

IN6 SAFETY SYRINGE, MODEL 3ML

FDA 510(k)

FDA Class 2 ·General Hospital

CARD GUARD, MODEL CG-2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

BraidE Embolization Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

K2 MOBILE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

HANAROSTENT LowAx Colon/Rectum (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic