PEDIATRIC VISION SCANNER

FDA 510(k)

FDA Class 2 ·Ophthalmic

DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

CMW CEMENT PRESSURISATION SYSTEM

FDA 510(k)

FDA Class 1 ·Orthopedic

KMW HIP PROSTHESIS POROUS COATED

FDA 510(k)

DEPUY CMW 1 GENTAMICIN BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

ANTI-KERATIN-HMW PRIMARY ANTI-BODY

FDA 510(k)

FDA Class 2 ·Immunology

DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37

FDA 510(k)

FDA Class 3 ·Cardiovascular

PROGRAMALITH III MODELS 238 & 239

FDA 510(k)

FDA Class 3 ·Cardiovascular

ISODYNE

FDA 510(k)

FDA Class 1 ·Dental

APPROACH HYDRO ST WIRE GUIDE, MODEL HMW

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEPUY CMW 1, 2 AND 3 BONE CEMENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)

FDA 510(k)

FDA Class 2 ·General Hospital

CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)

FDA 510(k)

FDA Class 2 ·General Hospital

CLAMPLESS VALVED CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)

FDA 510(k)

FDA Class 2 ·General Hospital

NEEDLE-FREE VALVED CONNECTOR AND CAP

FDA 510(k)

FDA Class 2 ·General Hospital

Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating

FDA 510(k)

FDA Class 2 ·Cardiovascular

PATIENTGALLERY IMAGING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

PEDIATRIC INGESTASCAN

FDA 510(k)

FDA Class 2 ·Ophthalmic

MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01

FDA 510(k)

FDA Class 2 ·Cardiovascular