Benchmark Intracranial Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Benchmark BMX96 Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAXReach Laser Probe

FDA 510(k)

FDA Class 2 ·Ophthalmic

NEAT 001

FDA 510(k)

FDA Class 2 ·Neurology

Sourcerer

FDA 510(k)

FDA Class 2 ·Neurology

Neu Platform

FDA 510(k)

FDA Class 2 ·Neurology

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

FDA 510(k)

FDA Class 2 ·Pathology

NUVUE COLORMARK9TM) NEEDLE

FDA 510(k)

FDA Class 2 ·Radiology

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

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

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

NTU-USB Ultrasound USB Box

FDA 510(k)

FDA Class 2 ·Radiology

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

KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology