SIR-Spheres Microspheres Activity Calculator (SMAC)

FDA 510(k)

FDA Class 2 ·Radiology

CAREGUIDE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEALIX ADVANCE PEEK ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

OBA-MCP, Orthodontic Bracket Adhesive with MCP

FDA 510(k)

FDA Class 2 ·Dental

Cytosponge Cell Collection Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST

FDA 510(k)

FDA Class 2 ·Hematology

BIS PEDIATRIC SENSOR

FDA 510(k)

FDA Class 2 ·Neurology

BTL-899 FP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VORTEX CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

PANALIGHT-BLU, MODEL 4175

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMITH & NEPHEW CDS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MED SCULPT

FDA 510(k)

FDA Class 2 ·Physical Medicine

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST

FDA 510(k)

FDA Class 2 ·Orthopedic

S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SMARTSUCTION SOLO DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CYNOSURE DERMATOLOGY LASER COOLING TIP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CEREC 2 CROWN SOFTWARE

FDA 510(k)

FDA Class 2 ·Dental