HELENA BIOSTRIP A

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

QUANTIMETRIX C-CLEAR(TM)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

URITEST 9, INLAB REAGENT STRIPS URINALY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

OSTEOBOOST-BMA

FDA 510(k)

FDA Class 2 ·General Hospital

VIRGO AMA ELISA KIT

FDA 510(k)

FDA Class 2 ·Immunology

TEST KIT, IIF-AMA

FDA 510(k)

FDA Class 2 ·Immunology

CMA CEREBRAL TISSUE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

CMA CEREBRAL TISSUE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Olive Plus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PRESTYL JET INJECTOR

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA

FDA 510(k)

FDA Class 2 ·Immunology

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

KALLESTAD FLORESCENT ANA/AMA/ASMA TEST

FDA 510(k)

FDA Class 2 ·Immunology

T/K (ATA/AMA) UNIVERSAL BIOPAK

FDA 510(k)

FDA Class 2 ·Immunology

Diode laser hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILGEL STC-S

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery