QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

STERIMED STERIZATION WRAPPER (NON-STERILE)

FDA 510(k)

FDA Class 2 ·General Hospital

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

LNI MGV MEDICAL GAS MIXER

FDA 510(k)

FDA Class 2 ·Anesthesiology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

Advocate Insulin Pen Needles

FDA 510(k)

FDA Class 2 ·General Hospital

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P (TM)

PEM 2400 PET SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),

FDA 510(k)

FDA Class 2 ·Neurology

MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION

FDA 510(k)

FDA Class 2 ·Neurology

FOCUS-PV BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

TIMX LOW BACK SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VSP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OMNI OXYGEN SYSTEM, MODEL 1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

INSUFFLATOR TUBING KIT W/FILTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

FDA 510(k)

FDA Class 2 ·Cardiovascular

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

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

EZ HUBER SAFETY INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital