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

FDA 510(k)

FDA Class 2 ·Pathology

PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PALINDROME H, SI, HSI CHRONIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheter, Hemodialysis, Implanted, Coated

FDA classification

FDA Class 2 ·Catheter, Hemodialysis, Implanted, Coated

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

APT TRACHEA TUBES

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA 510(k)

FDA Class 2 ·Immunology

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

CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY

FDA 510(k)

FDA Class 2 ·Ophthalmic

AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

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