CADIMAS VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

TERUMO DISPOSABLE HYPODERMC SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

WONDFO MULTI-DRUG URINE TEST CUP, PANEL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CUSTODIOL HTK SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FRONTLINE CANNABIS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CONTINUOUS EPIDURAL ANESTHESIA TRAY

FDA 510(k)

FDA Class 2 ·Anesthesiology

Molecular Flow Simulations

FDA 510(k)

FDA Class 2 ·Neurology

PRECLUDE SYNBLOC MEMBRANE

FDA 510(k)

FDA Class 2 ·Neurology

TM-300 TRACTION SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

PYMAH PRE-GAGED BALANCED TEMPA-KUFF

FDA 510(k)

FDA Class 2 ·Cardiovascular

SWIFT 2.0, MODEL 132.001

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENSI

FDA 510(k)

FDA Class 2 ·Cardiovascular

HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic