Monster BITE Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Breakaway Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

DERMABOND PRINEO Skin Closure System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KAEN YIH UMBILICAL CORD CLAMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

MEDRAD OPEN ENDED GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERABIEN ZR

FDA 510(k)

FDA Class 2 ·Dental

K-ETCHANT SYRINGE; NEEDLE TIP (E)

FDA 510(k)

FDA Class 2 ·Dental

MRINNERVU ENDORECTAL PROSTATE COIL

FDA 510(k)

FDA Class 2 ·Radiology

AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN

FDA 510(k)

FDA Class 2 ·Radiology

PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)

FDA 510(k)

FDA Class 2 ·Dental

THE BTE DYNAMIC LIFT

FDA 510(k)

FDA Class 2 ·Physical Medicine

INTERMATE XLV ELASTOMERIC INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

STOPCOCK MANIFOLD GANGS

FDA 510(k)

FDA Class 2 ·General Hospital

AIR FLOW SII

FDA 510(k)

FDA Class 2 ·Dental

DIOMED DELTA 25

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·LITTON TRANSCUTANEOUS CO2 SYSTEM

Cyclosporine Radioimmunoassay

FDA Pre-Market Approval

FDA Class 2 ·SANDIMMUNE(R) RADIOIMMUNOASSAY KIT

Baby Gorilla/Gorilla Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic