MAXReach Laser Probe

FDA 510(k)

FDA Class 2 ·Ophthalmic

ARGUS PB-3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MALE NATURAL RUBBER LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

BRAINTRACE

FDA 510(k)

FDA Class 2 ·Neurology

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

FDA 510(k)

FDA Class 2 ·Immunology

GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

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

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU

FDA 510(k)

FDA Class 2 ·Hematology

PATHIAM IMAGING SOFTWARE FOR HER2/NEU

FDA 510(k)

FDA Class 2 ·Hematology

SD-602 SD MODE 11, SD-603 SD MOD 111

FDA 510(k)

FDA Class 2 ·Neurology