FOUR LUMEN BLAKEMORE TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEAVER T-DRAIN & CATTEL T-DRAIN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CATHETER CARE TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COLE TUBE-LATEX

FDA 510(k)

FDA Class 2 ·Anesthesiology

FOAM HELMET - USE W/ESOPHAGEAL TAMPONA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FOLEY INSERTION TRAYS W/OVERWRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CELESTIN DILATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CANTOR TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URETEROSCOPY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

WINGED INFUSION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

ProSeal™ Closed System drug Transfer Device (CSTD)

FDA 510(k)

FDA Class 2 ·General Hospital

Laser Hair Growth Cap

FDA 510(k)

FDA Class 2 ·Physical Medicine

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·KONTUR SOFT (METHAFILCON A) CONTACT LNS

NEUROShield

FDA 510(k)

FDA Class 2 ·Radiology

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

MAGELLAN VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAGELLAN-2200, MODEL 1

FDA 510(k)

FDA Class 2 ·Anesthesiology