TEMREX ETCHING GEL

FDA 510(k)

FDA Class 2 ·Dental

PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Bipolar applicator CELON ProCurve V

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SCI-PHARM DESENSITIZING VARNISH

FDA 510(k)

FDA Class 2 ·Dental

OsteoMed PINNACLE Driver

FDA 510(k)

FDA Class 2 ·Dental

PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDRAD ENVISION CT INJECTOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERCOM II CEMENT

FDA 510(k)

FDA Class 2 ·Dental

BOSTON POST CEMENT

FDA 510(k)

FDA Class 2 ·Dental

KENDALL HOME RX THERAPEUTIC STOCKING

FDA 510(k)

FDA Class 2 ·General Hospital

SILICONE ELASTOMER SHEETING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·CLEARREAD DETECT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR