CAAS Workstation

FDA 510(k)

FDA Class 2 ·Radiology

Advanced Gynecological Applicator

FDA 510(k)

FDA Class 2 ·Radiology

Mistral-Air Warming Unit

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ceramill Zolid FX

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO SOLAR GI

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Vereos PET/CT

FDA 510(k)

FDA Class 2 ·Radiology

SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25

FDA 510(k)

FDA Class 2 ·Radiology

Philips Avent Comfort Single/Twin Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MFE COUCH ERGOMETER

FDA 510(k)

FDA Class 2 ·Physical Medicine

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

FDA 510(k)

FDA Class 2 ·Physical Medicine

Zenition 70

FDA 510(k)

FDA Class 2 ·Radiology

Bella-mu

FDA 510(k)

FDA Class 2 ·General Hospital

IMPRESSIX

FDA 510(k)

FDA Class 2 ·Dental

RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130

FDA 510(k)

FDA Class 2 ·Neurology

I4 (Integrated Intelligent Imaging Informatics) system

FDA 510(k)

FDA Class 2 ·Radiology

SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat