PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED

FDA 510(k)

FDA Class 2 ·Orthopedic

CSI/QCT

FDA 510(k)

FDA Class 2 ·Radiology

ADC QS/IPD WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

CLIRANS TAF06 HOLLOW FIBER DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MatriStem UBM Pericardial Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

OHMEDA MEDICAL GIRAFFE OMNIBED

FDA 510(k)

FDA Class 2 ·General Hospital

TERUMO ALLERGY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

RESTFUL NIGHTS, IST-APPLIANCE

FDA 510(k)

FDA Class 2 ·Dental

PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)

FDA 510(k)

FDA Class 2 ·Radiology

GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VIRGO(R) VZV-IGG ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

BACTEC MGIT 960 SIR KITS

FDA 510(k)

FDA Class 2 ·Microbiology

DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP

FDA 510(k)

FDA Class 2 ·General Hospital

AUGEASE VASCULAR AUGMENTATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILIMED SILICONE CARVING BLOCK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBU SILICONE RESUSCITATOR INFANT/CHILD

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRUTEK SELECT MODEL TT-1001

FDA 510(k)

FDA Class 2 ·General Hospital

PANASONIC TELE-HOMECARE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular