Kinepict Medical Imaging Tool 4.0

FDA 510(k)

FDA Class 2 ·Radiology

ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE

FDA 510(k)

FDA Class 2 ·Hematology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·4 OZ. STERILE UNPRESERVED SALINE SOLUTION

CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A

FDA 510(k)

FDA Class 2 ·General Hospital

ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)

FDA 510(k)

FDA Class 2 ·Hematology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE SALINE PRESERVED SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE SALINE PRESERVED SOLUTION

TOMOGSCANNER 2

FDA 510(k)

FDA Class 2 ·Radiology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE SALINE PRESERVED SOLUTION

EDEN ControlCath

FDA 510(k)

FDA Class 2 ·Anesthesiology

EDEN Peek Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

EDEN Spinal Fixation MIS System

FDA 510(k)

FDA Class 2 ·Orthopedic

EDEN Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE

PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UniStrip1 Generic Blood Glucose Test Strips

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PRODIGY iConnect Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry