SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1

FDA 510(k)

FDA Class 2 ·Hematology

DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

FDA 510(k)

FDA Class 2 ·Radiology

ONYX

FDA 510(k)

FDA Class 2 ·Hematology

COULTER Z 1

FDA 510(k)

FDA Class 2 ·Hematology

HI-TORQUE POWERTURN

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGNETOM Amira

FDA 510(k)

FDA Class 2 ·Radiology

GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

FDA 510(k)

FDA Class 2 ·Radiology

SUPER SHEATH XL INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNCHRON MULTI CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NC TREK RX CORONARY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM Vida with syngo MR XA50A

FDA 510(k)

FDA Class 2 ·Radiology

UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

READY VIEW

FDA 510(k)

FDA Class 2 ·Radiology

MULTIX Impact

FDA 510(k)

FDA Class 2 ·Radiology

syngo. CT Neuro Perfusion

FDA 510(k)

FDA Class 2 ·Radiology

GE 8CH FOOT ANKLE COIL

FDA 510(k)

FDA Class 2 ·Radiology