VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

TUTOPATCH, TUTOMESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIDECO PEDIATRIC ARTERIAL FILTERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC

FDA 510(k)

FDA Class 2 ·Orthopedic

QUICKSET MIMIX BONE VOID FILLER

FDA 510(k)

FDA Class 2 ·Neurology

EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP

FDA 510(k)

FDA Class 2 ·Hematology

TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY

FDA 510(k)

FDA Class 2 ·Radiology

TSX-301A, AQUILION ONE CT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS

FDA 510(k)

FDA Class 2 ·General Hospital

COMPRESS DISTAL FEMORAL REPLACEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

DISPENSING PIN WITH ONE-WAY VALVE

FDA 510(k)

FDA Class 2 ·General Hospital

BONE PLATE WITH CABLES

FDA 510(k)

FDA Class 2 ·Orthopedic

M/D4 W/CHARGER (CARDIOPAC 3M11)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WHEEL-O-VATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYSTEM 97

FDA 510(k)

FDA Class 2 ·Cardiovascular

CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION

FDA 510(k)

FDA Class 2 ·Radiology