BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

System, Test, Her-2/Neu, Monitoring

FDA classification

FDA Class 2 ·System, Test, Her-2/Neu, Monitoring

Aveli

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BCW POWER ADVANTAGE WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

BCW 600 POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

CMDR 2CW (Multiple models)

FDA 510(k)

FDA Class 2 ·Radiology

Athena Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Willow Wearable Breast Pump 2.0

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

UST-2266U-5 CW DOPPLER TRANSDUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style

FDA 510(k)

FDA Class 2 ·Anesthesiology

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE TM 2501

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE MODEL 3500

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE CLEANER,15ML NEW SAMPLE SIZE

TUTTNAUER TABLE-TOP AUTOCLAVE

FDA 510(k)

FDA Class 2 ·General Hospital

SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE

FDA 510(k)

FDA Class 2 ·General Hospital