E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS

FDA 510(k)

FDA Class 2 ·Radiology

CushionCast Moldable Cushions

FDA 510(k)

FDA Class 2 ·Radiology

Osteo-site Vertebral Balloon

FDA 510(k)

FDA Class 2 ·Orthopedic

Navigated Pedicle Access Kit

FDA 510(k)

FDA Class 2 ·Neurology

MRI LINE MARKER

FDA 510(k)

FDA Class 2 ·Radiology

ERGO SRS

FDA 510(k)

FDA Class 2 ·Radiology

KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6

FDA 510(k)

FDA Class 2 ·Dental

WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rugged Oxygen Generator (ROG) (RO01-00001)

FDA 510(k)

FDA Class 2 ·Anesthesiology

WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KidneyIntelX.dkd

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TSRH SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NeoSpan Compression Staple Impant w/instruments

FDA 510(k)

FDA Class 2 ·Orthopedic

ERA 2000A

FDA 510(k)

FDA Class 2 ·Anesthesiology

PIVOX(tm) Oblique Lateral Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

HAND HELD MEDISPACER

FDA 510(k)

FDA Class 2 ·Anesthesiology

EVOS Pelvic and Acetabular System

FDA 510(k)

FDA Class 2 ·Orthopedic

STAT GAS MODULE

FDA 510(k)

FDA Class 2 ·Anesthesiology

EVOS Patella Plates

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic