ARTHROSCOPIC ACL DRILL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO

FDA 510(k)

FDA Class 2 ·Radiology

AMBU MATIC AUTOMATIC RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO HBS HEADLESS BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

NORMED BONE TRANSPORT DISTRACTION DEVICE

FDA 510(k)

FDA Class 2 ·Dental

REGAIN STAND-UP WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®

FDA 510(k)

FDA Class 2 ·General Hospital

DERMABOND NX ADHESIVE MODEL: DNX6, DNX12

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COLTENE PRESIDENT IMPRESSION MATERIALS

FDA 510(k)

FDA Class 2 ·Dental

CONPHAR STOMACH TUBE-STERILE-X-RAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTERFACE PRE BYPASS PRIME FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.

FDA 510(k)

FDA Class 2 ·Orthopedic

SECOND GENERATION KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI

FDA 510(k)

FDA Class 2 ·General Hospital

OASIS

FDA 510(k)

FDA Class 2 ·Radiology