BI-RADS COMPANION

FDA 510(k)

FDA Class 2 ·Radiology

GIRAFFE INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

INNER PEACE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BACTEC CULTURE VIALS, LYTIC, ANAEROBIC

FDA 510(k)

FDA Class 1 ·Microbiology

REDLINE ANTHRAX ALERT TEST

FDA 510(k)

FDA Class 2 ·Microbiology

REST X SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

IMPLEX CONTINUUM POROUS PATELLAR

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS

FDA 510(k)

FDA Class 2 ·Ophthalmic

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE

FDA 510(k)

FDA Class 2 ·Microbiology

MALT EXTRACT

FDA 510(k)

FDA Class 1 ·Microbiology

PGDx elio tissue complete

FDA 510(k)

FDA Class 2 ·Pathology

MAST LUMINESCENT ALLERGY SYS

FDA 510(k)

FDA Class 2 ·Immunology

MODEL 250CX SERIES MATERNAL/FETAL MONITOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMRX

FDA 510(k)

FDA Class 2 ·Radiology

DISPOSABLE HEMOSTATS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

PRODIGY CHOICE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

XENON LIGHT SOURCE MODEL LS6000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMZ - DENTAL IMPLANT O-RING ATTACHMENT

FDA 510(k)

FDA Class 2 ·Dental