SPECTRUM V.0

FDA 510(k)

FDA Class 2 ·Radiology

NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta

FDA 510(k)

FDA Class 2 ·Orthopedic

SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY

FDA 510(k)

FDA Class 2 ·Dental

ARTISAN AESTHETIC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

KENSEY NASH ECM SURGICAL PATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMILEBOND SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MRI MARKER

FDA 510(k)

FDA Class 2 ·Radiology

SORIN C5 SYSTEM MODEL 58-00-00

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURGICAL TISSUE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37

FDA 510(k)

FDA Class 2 ·Hematology

BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRYOTOP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MYOGUIDE SYSTEM MODEL 8008

FDA 510(k)

FDA Class 2 ·Anesthesiology

EMS AIR-FLOW MASTER PIEZON

FDA 510(k)

FDA Class 2 ·Dental

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NVISION VLE IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ELECSYS FOLATE II CALSET II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry