THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

AKRON ATP9 TRACTION MACHINE

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODIFIED DR-2C/PMC 100

FDA 510(k)

FDA Class 2 ·Cardiovascular

CYTOBRUSH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

RejuvaKnee™ Collagen Meniscus Implant

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERMANENT SILICONE CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCIN ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VINGMED DS100 DOPPLER FLOWMETER

FDA 510(k)

FDA Class 2 ·Radiology

SPERMCHECK VASECTOMY

FDA 510(k)

FDA Class 2 ·Hematology

A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO EBI SPINELINK SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ROCHE REAGENT FOR GLUCOSE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANCOR

FDA 510(k)

FDA Class 2 ·Radiology