Digiscan FDX

FDA 510(k)

FDA Class 2 ·Radiology

Cardiovascular Angiography System

FDA 510(k)

FDA Class 2 ·Radiology

DigiX FDX

FDA 510(k)

FDA Class 2 ·Radiology

Wireless/Wired X-Ray Flat Panel Detectors

FDA 510(k)

FDA Class 2 ·Radiology

Stealth-Midas MR8 System

FDA 510(k)

FDA Class 2 ·Neurology

IDI-MRSA

FDA 510(k)

FDA Class 2 ·Microbiology

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

FDA 510(k)

FDA Class 2 ·Neurology

ULTRATONE 8+ & 20

FDA 510(k)

FDA Class 2 ·Physical Medicine

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD Nano 2nd Gen Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS

FDA 510(k)

FDA Class 2 ·Ophthalmic

WAKO (TM) AUTOKIT GOT TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

PRECISION UV (VASURFILCON A)

FDA 510(k)

FDA Class 2 ·Ophthalmic

BD Hypodermic Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

BT-1000

FDA 510(k)

FDA Class 2 ·Neurology

Hi bebe super (Models BT-150S and BT-150L)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Infant Phototherapy Equipment

FDA 510(k)

FDA Class 2 ·General Hospital

Hi bebe plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology