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

MAGNA SURGEONS GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMPHASYS Acetabular System

FDA 510(k)

FDA Class 2 ·Orthopedic

Urea Nitrogen2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEUROTECH BAXOLVE TYPE 294

FDA 510(k)

FDA Class 2 ·Neurology

RECLAIM Monobloc Revision Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

Pirouette 018

FDA 510(k)

FDA Class 2 ·Cardiovascular

Innovo

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Guardenia (GAR-1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATTUNE™ Revision Hinge Knee

FDA 510(k)

FDA Class 2 ·Orthopedic

OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN

FDA 510(k)

FDA Class 2 ·Immunology

NexSite HD, Hemodialysis Step Tip Catheter (60cm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEPUY GLOBAL UNITE SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology