MODIFICATION TO INSPIRATION VENTILATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

GLOBAL UNITE™ Platform Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

BANTAM CATHETER (280MM BALLOON LENGTHS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLASMATRODE SALINE SAFE TUR ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cathivex ¿GV filter units

FDA 510(k)

FDA Class 2 ·General Hospital

EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Halo One Thin-Walled Guiding Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

RANDOX MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Advocate PTA Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Attune Revision Sleeve LPS Femoral Adaptors

FDA 510(k)

FDA Class 2 ·Orthopedic

Préime DermaFacial Collagen+

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Emerge Monorail PTCA Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294

FDA 510(k)

FDA Class 2 ·Neurology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Zilver 635 Biliary Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRYKER ESSX MICRODEBRIDER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology