BANTAM,48XXXXXX, 50XXXXXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

neoClose PDS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYSTEM-ARMS, MODEL 390,E60

FDA 510(k)

FDA Class 2 ·Physical Medicine

COLLEXA

FDA 510(k)

FDA Unclassified ·Unknown

Alkaline Phosphatase2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COLLACARE DENTAL

FDA 510(k)

FDA Unclassified ·Unknown

CORAIL Cemented Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

MEDICAL AIR COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Evolution Esophageal Stent System – Partially Covered

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KNEEHAB XP CONTROLLER, MODEL 411

FDA 510(k)

FDA Class 2 ·Physical Medicine

PneumoLiner

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

COOK IRELAND SONNET POLYPECTOMY SNARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUARDIAN II HEMOSTASIS VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HbA1c Advanced

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INHANCE™ Shoulder System, Sterile Single Use Instrumentation

FDA 510(k)

FDA Class 2 ·Orthopedic

Pro-X1™ Trochanteric Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular