MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay

FDA 510(k)

FDA Class 2 ·Pathology

EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO

FDA 510(k)

FDA Class 2 ·Orthopedic

PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

EDWARDS ADJUSTABLE CONNECTORS

FDA 510(k)

FDA Class 2 ·Orthopedic

Q-Switched Nd:Yag laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADVANCED TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Protective Face Mask for Medical Use

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Mask-Model Number CW01

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AQUASENS FLUID MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST

FDA 510(k)

FDA Class 2 ·Immunology

DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AC3™ Range™ Intra-Aortic Balloon Pump

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2

FDA 510(k)

FDA Class 2 ·Immunology

ASTHMAKIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

IMMUNODOT LYME TEST

FDA 510(k)

FDA Class 2 ·Microbiology

AMNIOINFUSION CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMMUNOWELL TPO (MICROSOME) TEST

FDA 510(k)

FDA Class 2 ·Immunology