CARDIOINTEGRAM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIO Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TORSO ARRAY COIL, MODEL 558GE-64

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 445SI-64E QUADRATURE WRIST COIL

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL

FDA 510(k)

FDA Class 2 ·Radiology

AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12

FDA 510(k)

FDA Class 2 ·Radiology

TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)

FDA 510(k)

FDA Class 2 ·Orthopedic

AGC AND MAXIM KNEE COMPONENTS WITH NTS

FDA 510(k)

FDA Class 2 ·Orthopedic

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

FDA 510(k)

FDA Class 2 ·Microbiology

PHARMACIA IGE RIA MODIFIED

FDA 510(k)

FDA Class 2 ·Immunology

SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5

FDA 510(k)

FDA Class 2 ·Immunology

IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH

FDA 510(k)

FDA Class 2 ·Immunology