CARDIOLIPIN IGA EIA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CHALLENGE 8000 POWERED MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

FIXION INTERLOCKING NAIL (FIXION IL NAIL)

FDA 510(k)

FDA Class 2 ·Orthopedic

PI-PHEUMO INTESTINAL INSTRUMENT SET

FDA 510(k)

FDA Class 2 ·General Hospital

CLEARPOINT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·O.P.R. -55 SOFT CONTACT LENS

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·(MAFILCON) SOFT CONTACT LENSES

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·O.P.R. -55 SOFT CONTACT LENS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC