TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMOGLOBIN

FDA 510(k)

FDA Class 2 ·Hematology

PERCUTANEOUS INTRODUCER: SELDINGER STYLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PARAMAX ALKALINE PHOSPHATASE REAGENT-

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TETRAFLEX INTEGRALLY SUPPORTED PTFE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SONGER CABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAMOSPAT

FDA 510(k)

FDA Class 2 ·Radiology

REFLEX(TM) CA-T CLIP APPLIER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYRINGEFILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PRN PLUS + INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

FUJI IONOMER TYPE I & II

FDA 510(k)

FDA Class 2 ·Dental

NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority

FDA 510(k)

FDA Class 2 ·Neurology

MICHIGAN CRANIAL RESHAPING ORTHOSIS

FDA 510(k)

FDA Class 2 ·Neurology

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLINICAL DATA SYSTEM (CAM) MODULE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO EPTFE GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC

FDA 510(k)

FDA Class 2 ·Dental

ANTIGEN CONTROL CELLS

FDA 510(k)

FDA Class 2 ·Microbiology

SPOR-TEST-STRIP

FDA 510(k)

FDA Class 2 ·General Hospital