MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DENE BRIDGE

FDA 510(k)

FDA Class 2 ·Dental

Origin Coxa Vara Hip Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

GYDER® Hip System

FDA 510(k)

FDA Class 2 ·Neurology

Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head

FDA 510(k)

FDA Class 2 ·Orthopedic

Personal Kinetigraph (PKG) System Gen 2 Plus

FDA 510(k)

FDA Class 2 ·Neurology

EPS320 CARDIAC STIMULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TROPHON

FDA 510(k)

FDA Class 2 ·Radiology

VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Precision Screw

FDA 510(k)

FDA Class 2 ·Neurology

ACCUSONIC ADVANTAGE

FDA 510(k)

FDA Class 2 ·Physical Medicine

COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG

FDA 510(k)

FDA Class 2 ·Neurology

RITRACT SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

HEARTEVENT, MODEL AT

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROMONICS TINNITUS TREATMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Xprecia Prime Coagulation System

FDA 510(k)

FDA Class 2 ·Hematology

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

FDA 510(k)

FDA Class 2 ·Neurology