Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

GIL-MED PARENTERAL NUTRITION OR MEDICINE

FDA 510(k)

FDA Class 2 ·General Hospital

GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..

FDA 510(k)

FDA Class 2 ·Orthopedic

FLEXGARD SYRINGE PROTECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

FIBRINOGEN CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

N/T PROTEIN CONTROL PY

FDA 510(k)

FDA Class 2 ·Hematology

GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3

FDA 510(k)

FDA Class 2 ·Hematology

LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2

FDA 510(k)

FDA Class 2 ·Hematology

N/T PROTEIN CONTROL PY

FDA 510(k)

FDA Class 2 ·Hematology

PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2

FDA 510(k)

FDA Class 2 ·Hematology

FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3

FDA 510(k)

FDA Class 2 ·Hematology

SNAP MODEL 5

FDA 510(k)

FDA Class 2 ·Anesthesiology

Spirit Hair Removal laser Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

neoV980 & neoV1470 Diode Lasers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SNAP TESTING DEVICE

FDA 510(k)

FDA Class 2 ·Anesthesiology