REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GV3000 PHACOEMULSIFIER/FRAGMENTER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Drivewire 24 Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Overjet Caries Assist

FDA 510(k)

FDA Class 2 ·Radiology

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

WINGED INFUSION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

Sublime Radial Access 018 RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

WARSAW ORTHOPEDIC BONE PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

TENS STIMULATOR, MODELS 2800 AND 3000

FDA 510(k)

FDA Class 2 ·Neurology

DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates

FDA 510(k)

FDA Class 2 ·Orthopedic

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery