PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE

FDA 510(k)

FDA Class 2 ·Cardiovascular

OCCLUSION BALLOON CATHETER MODEL OBC

FDA 510(k)

FDA Class 2 ·Cardiovascular

EQUIMATRIX

FDA 510(k)

FDA Class 2 ·Dental

VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IcePearl 2.1 CX L, IceForce 2.1 CX L

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

KOTEX SECURITY TUBE TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376

FDA 510(k)

FDA Class 2 ·Hematology

REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A

FDA 510(k)

FDA Class 2 ·Radiology

TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CSR

FDA 510(k)

FDA Class 2 ·Dental

COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

BOND-1 C & B

FDA 510(k)

FDA Class 2 ·Dental

DENTAL FACE MASKS, POLYESTER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPIFE LD-12 KIT, MODEL 3338

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASCENSIA DEX 2 DIABETES CARE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE

FDA 510(k)

FDA Class 2 ·Dental

CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECSYS CA 15-3 CALCHECK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry