KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

CPU GRAPH

FDA 510(k)

FDA Class 2 ·Anesthesiology

NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CPU 1100 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA 510(k)

FDA Class 2 ·Pathology

CPU-1 INTENSIVE CARE VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAXReach Laser Probe

FDA 510(k)

FDA Class 2 ·Ophthalmic

EZ-CIRC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OHMEDA CPU AIR COMPRESSOR MODEL 3350

FDA 510(k)

FDA Class 2 ·Anesthesiology

OHIO CPU-1 INTENSIVE CARE VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

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

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SALUMEDICA NERVE CUFF

FDA 510(k)

FDA Class 2 ·Neurology

ESG-300, APU-300, Pressure Reducer, MAPC Probes

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ULE-2, MULE-2, HAND ACCESSORY KIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

A1 ACOUSTIC RHINOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology