RAPID TOX CUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PHADEBACT MONOCLONAL GC TEST, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

UNITOX BOTOX SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI

FDA 510(k)

FDA Class 2 ·Immunology

CROSSVENT-4 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

STRAIGHT-LINES I.V. ORGANIZER

FDA 510(k)

FDA Class 2 ·General Hospital

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEUROTECH BAXOLVE TYPE 294

FDA 510(k)

FDA Class 2 ·Neurology

FEEDBACK EMG SYSTEM, MODEL PE-L00

FDA 510(k)

FDA Class 2 ·Neurology

RAPID DRUG SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

'RAPIDONE'-METHADONE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MX-7000 MICROXEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Innovo

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATOVEN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SLS-CT

FDA 510(k)

FDA Class 2 ·Radiology

'RAPIDTEC 4' TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology