BRISTOL BALLON INTRODUCER, MANDRIL SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CANDELA GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endoscope Introducer Kit

FDA classification

FDA Class 2 ·Endoscope Introducer Kit

NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Neu Platform

FDA 510(k)

FDA Class 2 ·Neurology

MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L

FDA 510(k)

FDA Class 2 ·Neurology

OMNILUX NEW-U

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

FDA 510(k)

FDA Class 2 ·Pathology

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

FDA 510(k)

FDA Class 2 ·Immunology

WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GLUTARTEST 1 REAGENT STRIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HIGH RANGE PEROXIDE TEST STRIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCANVIEW HER2/NEU FISH SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NEU-PULS(TENS) MODEL #295

FDA 510(k)

FDA Class 2 ·Neurology

ARIOL HER-2/NEU FISH

FDA 510(k)

FDA Class 2 ·Immunology

ARIOL HER-2/NEU IHC

FDA 510(k)

FDA Class 2 ·Hematology

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology

BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Her-2, ER, PR IHControls

FDA 510(k)

FDA Class 2 ·Hematology