SMART DOSE(TM)

FDA 510(k)

FDA Class 2 ·General Hospital

SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE SURGICAL MASK (MODIFIED)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

System, Imaging, Optical Coherence Tomography (Oct)

FDA classification

FDA Class 2 ·System, Imaging, Optical Coherence Tomography (Oct)

MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION

FDA 510(k)

FDA Class 2 ·Neurology

ENDOFORM RECONSTRUCTIVE TEMPLATE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

URETEROSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COPD LIQUID OXYGEN PORTABLE, MODEL 300P

FDA 510(k)

FDA Class 2 ·Anesthesiology

EXTT-101

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ERCHONIA ML SCANNER (MLS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHAKOFF ENDOSCOPY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WINGED NON-CORING NEEDLE SET

FDA 510(k)

FDA Class 2 ·General Hospital

Confirm Rx Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5

FDA 510(k)

FDA Class 2 ·Orthopedic

CEMEX SYSTEM GUN APPLICATION VERSION

FDA 510(k)

FDA Class 2 ·Orthopedic

DISPOSABLE NEEDLE COUNTER (20-560)

FDA 510(k)

FDA Class 2 ·General Hospital

CPS DIRECT SL II SLITTABLE OUTER CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FEMTO LDV

FDA 510(k)

FDA Class 2 ·Ophthalmic