HEARTRAK AF

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOCYTE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EBI XFIX DFS RAIL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BOSWORTH CORACO-CLAVICULAR SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

PE-3000 PULSE RATE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

COLLIMATOR, MODEL M-38

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Tyber Medical MST Trauma Screw

FDA 510(k)

FDA Class 2 ·Orthopedic

PENTAX EPK-I5010 VIDEO PROCESSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EPICARE-DUO LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OptikView GUP2103CMI

FDA 510(k)

FDA Class 2 ·Radiology

ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER

FDA 510(k)

FDA Class 2 ·General Hospital

TROJAN Fire & Ice lubricated male natural rubber latex condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS

FDA 510(k)

FDA Class 2 ·Cardiovascular

USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAP SYSTEM RAST ASM/RIA AND ASM/FEIA

FDA 510(k)

FDA Class 2 ·Immunology

CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COLTOLUX LIGHT METER

FDA 510(k)

FDA Class 2 ·Dental