SPECTRALIS with Flex Module

FDA 510(k)

FDA Class 2 ·Ophthalmic

Unyvero LRT BAL Application

FDA 510(k)

FDA Class 2 ·Microbiology

Leica FL400

FDA 510(k)

FDA Class 2 ·Neurology

Spectralis HRA+OCT and variants with OCT Angiography Module

FDA 510(k)

FDA Class 2 ·Ophthalmic

Spectralis HRA+OCT and variants with High Magnification Module

FDA 510(k)

FDA Class 2 ·Ophthalmic

Spectralis HRA + OCT and variants

FDA 510(k)

FDA Class 2 ·Ophthalmic

PAPCONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

X TWIN SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE

FDA 510(k)

FDA Class 2 ·General Hospital

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A

FDA 510(k)

FDA Class 2 ·Radiology

HAYMAX

FDA 510(k)

FDA Class 2 ·General Hospital

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PROTEX, TAHITI CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

extriCARE® 3000 Negative Wound Pressure Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SpermAlign Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Air Next

FDA 510(k)

FDA Class 2 ·Anesthesiology

RANEY CLIPS

FDA 510(k)

FDA Class 2 ·Neurology

MODULOCK POSTERIOR SPINAL FIXATION

FDA 510(k)

FDA Class 2 ·Orthopedic