GDS ENZYMATIC THEOPHYLLINE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE

FDA 510(k)

FDA Class 2 ·Radiology

REGENEREX POROUS TITANIUM SLEEVE AUGMENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

BADGWELL SAMPLING CATHETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DUREX ULTRA COMFORT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000

FDA 510(k)

FDA Class 2 ·Anesthesiology

CELSITE(TM) BRACHIAL VENOUS PORT

FDA 510(k)

FDA Class 2 ·General Hospital

BRAUN DIACAN(R) FISTULA NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COOK ASPIRATION/IRRIGATION UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

H-H FLUSHING RESERVOIR

FDA 510(k)

FDA Class 2 ·Neurology

MODEL 600GE-64: BILATERAL BREAST COIL

FDA 510(k)

FDA Class 2 ·Radiology

LIGHTWRITER

FDA 510(k)

FDA Class 2 ·Physical Medicine

MAXFIRE MARXMEN MENISCAL REPAIR DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

VARAPULSE-2

FDA 510(k)

FDA Class 2 ·Physical Medicine

CHROM Z-F:VIII, CAT. NO. 5241

FDA 510(k)

FDA Class 2 ·Hematology