IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POLAR CATH PERIPHERAL DILATATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYSMEX HEMATOLOGY SYSTEM ACCESSORIES

FDA 510(k)

FDA Class 2 ·Hematology

ATH CERAMIC UHMWPE TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROTHERM MT-501 & MT-502

FDA 510(k)

FDA Class 2 ·General Hospital

ELECTRO-NERVE STIMULATOR B4/B400

FDA 510(k)

FDA Class 2 ·Neurology

HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT

FDA 510(k)

FDA Class 2 ·Immunology

COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2

FDA 510(k)

FDA Class 2 ·Immunology

THREADED FIXATION PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR

FDA 510(k)

FDA Class 2 ·Orthopedic

SprintRay High Impact Denture Base

FDA 510(k)

FDA Class 2 ·Dental

OSADA ENAC

FDA 510(k)

FDA Class 2 ·Dental

EU-TTG IGA AND EU-TTG IGG

FDA 510(k)

FDA Class 2 ·Immunology

VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

myPatch-s

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS

FDA 510(k)

FDA Class 2 ·Dental

IMMULITE TOXOPLASMA QUANTITATIVE IGG

FDA 510(k)

FDA Class 2 ·Microbiology