SPEC Model M23

FDA 510(k)

FDA Class 2 ·Radiology

CRYOPEN AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MYCO-FLUOR REAGENT A & B

FDA 510(k)

FDA Class 1 ·Hematology

SERAGARD INJECTION PATCH

FDA 510(k)

FDA Class 1 ·General Hospital

TRANQUIL TRI-BTE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INOMAX DS(IR) (DELIVERY SYSTEM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMORPHUS SILK BY DENTRAX

FDA 510(k)

FDA Class 2 ·Dental

THE TUCKER SLING

FDA 510(k)

FDA Class 1 ·General Hospital

PREVENTETTE (CONDOM)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENDOCERVICAL ASPIRATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

FDA 510(k)

FDA Class 1 ·General Hospital

VIBROFLEX

FDA 510(k)

FDA Class 1 ·Physical Medicine

Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)

FDA 510(k)

FDA Class 2 ·Dental

SPEC MODEL M-31

FDA 510(k)

FDA Class 2 ·Radiology

MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IR-192 IMPLANT -- MODIFICATION

FDA 510(k)

FDA Class 2 ·Radiology

MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)

FDA 510(k)

FDA Class 2 ·Neurology

CSPI SPECIMEN TRAP (NON-STERILE)

FDA 510(k)

FDA Class 2 ·General Hospital

IR-192 IMPLANT

FDA 510(k)

FDA Class 2 ·Radiology

GEL FILLED GUM SOOTHER

FDA 510(k)

FDA Class 2 ·Dental