VIDAS LYME IGG

FDA 510(k)

FDA Class 2 ·Microbiology

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

INDIBA COMPACT devices

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1

FDA 510(k)

FDA Class 2 ·Radiology

SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FASTPACK TSH IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT

FDA 510(k)

FDA Class 2 ·Anesthesiology

PLURIMUS CARDIAC EVALUATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROC LUMBAR PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO MINISPIR, SPIROLAB III

FDA 510(k)

FDA Class 2 ·Anesthesiology

COMFORT - CUF

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

FDA 510(k)

FDA Class 2 ·Radiology

FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPIROTEL

FDA 510(k)

FDA Class 2 ·Anesthesiology

NOVEL VBR SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VIDAS LYME IGM

FDA 510(k)

FDA Class 2 ·Microbiology

MINISPIR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TAMARACK ANTERIOR THORACOLUNBAR

FDA 510(k)

FDA Class 2 ·Orthopedic

FIRSTTEMP GENIUS

FDA 510(k)

FDA Class 2 ·General Hospital