BT-1000

FDA 510(k)

FDA Class 2 ·Neurology

Hi bebe super (Models BT-150S and BT-150L)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Infant Phototherapy Equipment

FDA 510(k)

FDA Class 2 ·General Hospital

Hi bebe plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSOFT(TM) VASCULAR GRAFT

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSOFT(TM) VASCULAR GRAFT

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II ASSAY

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSEAL(TM) VASCULAR GRAFT

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·PRO-TRAC II TACROLIMUS ELISA KIT

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSEAL(TM) VASCULAR GRAFT

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TACROLIMUS II

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·GELSEAL TM TRIAXIAL VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MONOLISA ANTI-HAV EIA

FDA 510(k)

FDA Class 2 ·Microbiology