POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RecoveryAir PRO

FDA 510(k)

FDA Class 2 ·Physical Medicine

ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5

FDA 510(k)

FDA Class 2 ·Immunology

SR-MODEL 230 (MODIFICATION)

FDA 510(k)

FDA Class 2 ·General Hospital

DOUBLE ANTIBODY SERUM BENZODIAZEPINES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IMMULITE CORTISOL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

FDA 510(k)

FDA Class 2 ·Neurology

IGE EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

FDA 510(k)

FDA Class 2 ·Microbiology

Integrated CardioRespiratory System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C

FDA 510(k)

FDA Class 2 ·Neurology

OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EMC MODEL NO. STATOME 900

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TIO-H DIGITAL RADIOGRAPHY SENSOR

FDA 510(k)

FDA Class 2 ·Dental

DIGITAL IMAGER

FDA 510(k)

FDA Class 2 ·Radiology