SYNGO IMAGING (VERSION V30)

FDA 510(k)

FDA Class 2 ·Radiology

Eonis SCID-SMA kit

FDA 510(k)

FDA Class 2 ·Immunology

SIENET COSMOS (VERSION V15A)

FDA 510(k)

FDA Class 2 ·Radiology

SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)

FDA 510(k)

FDA Class 2 ·Dental

ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QEVO System

FDA 510(k)

FDA Class 2 ·Neurology

Neonatal Phototherapy System

FDA 510(k)

FDA Class 2 ·General Hospital

JETT PLASMA Medical II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Promaxo MRI System

FDA 510(k)

FDA Class 2 ·Radiology

NeoBase 2 Non-derivatized MSMS Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INVIDOS

FDA 510(k)

FDA Class 2 ·Radiology

DPD-12PCC

FDA 510(k)

FDA Class 2 ·Radiology

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PHARMETRIX MEDIPUMP MODEL 524

FDA 510(k)

FDA Class 2 ·General Hospital

TCB TEMPORARY CROWN AND BRIDGE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

TRACOE silcosoft Tracheostomy Tube

FDA 510(k)

FDA Class 2 ·Anesthesiology

T34L SYRINGE DRIVER

FDA 510(k)

FDA Class 2 ·General Hospital

CYFRA 21-1 EIA MODEL 211-10

FDA 510(k)

FDA Class 2 ·Immunology