CRC-77tHR

FDA 510(k)

FDA Class 2 ·Radiology

IQ GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViziShot 2 FLEX

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)

FDA 510(k)

FDA Class 2 ·Neurology

MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260

FDA 510(k)

FDA Class 2 ·Cardiovascular

KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESTEYA

FDA 510(k)

FDA Class 2 ·Radiology

HELONTIX VENT

FDA 510(k)

FDA Class 2 ·Anesthesiology

CLAVIS

FDA 510(k)

FDA Class 2 ·Anesthesiology

EndoTool IV 1.10

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIMUPLAN TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK

FDA 510(k)

FDA Class 2 ·Microbiology

GENTAMICIN DISK (120MCG)

FDA 510(k)

FDA Class 2 ·Microbiology

SCD STERILE CONNECTION DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIM 4000C

FDA 510(k)

FDA Class 2 ·Radiology

PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION

FDA 510(k)

FDA Class 2 ·Anesthesiology

HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING

FDA 510(k)

FDA Class 2 ·Orthopedic

N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry