WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

CRYOPETTE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MUELLER TYPE FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TECHNO-SCOPE VISUAL STETHOSCOPE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1

FDA 510(k)

FDA Class 2 ·Radiology

OHMEDA MEDICAL OMNIBED

FDA 510(k)

FDA Class 2 ·General Hospital

ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY

FDA 510(k)

FDA Class 2 ·Radiology

RTDOSEPLAN

FDA 510(k)

FDA Class 2 ·Radiology

PATHFAST CTNL CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

J-SCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TAMARIN BLUE PTCA RX DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ILO292 DP ECHOPORT PLUS OAE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BTM TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S

FDA 510(k)

FDA Class 2 ·Orthopedic

CAPIOX(R) BUBBLE TRAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

uNion Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic