JANUS I

FDA 510(k)

FDA Class 2 ·Radiology

PRESSUREGUARD IV

FDA 510(k)

FDA Class 2 ·General Hospital

PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNIDUS MALE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CHOLANGIOGRAPHY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THERMOSKIN CONDUCTIVE PADS

FDA 510(k)

FDA Class 2 ·Neurology

HCG-NOSTICK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIRTEC2 LOW AIR LOSS THERAPY BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

ENTRAVISION EP-500 I/A ECCO PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Wilson-Cook Achalasia Balloon

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENTERAL FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ECHOENCODER

FDA 510(k)

FDA Class 2 ·Radiology

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)

FDA Class 2 ·Hematology

DX-D IMAGING PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

CONTOUR II SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SKINTELL

FDA 510(k)

FDA Class 2 ·Radiology