SyntrFuge System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNI OXYGEN SYSTEM, MODEL 1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

MOSAIQ Oncology Information System

FDA 510(k)

FDA Class 2 ·Radiology

INSUFFLATOR TUBING KIT W/FILTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EON

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Synq Software Version 1.3

FDA 510(k)

FDA Class 2 ·Radiology

ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS

FDA 510(k)

FDA Class 2 ·Dental

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO URESTA PESSARY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH

FDA 510(k)

FDA Class 2 ·General Hospital

activL® Next Generation Instrumentation

FDA 510(k)

FDA Class 2 ·Orthopedic

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

GLOBAL HEALTHCARE FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892

FDA 510(k)

FDA Class 2 ·Neurology

ShefaBone SCPC Resorbable Bone Graft

FDA 510(k)

FDA Class 2 ·Dental

FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTASE PHE/GAL SCREENING ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPTUM TELEHEALTH APPLICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFESYS PACS

FDA 510(k)

FDA Class 2 ·Radiology