NICHOLS ADVANTAGE ALDOSTERONE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)

FDA 510(k)

FDA Class 2 ·Ophthalmic

COAT-A-COUNT NO-EXTRACTION ALDOSTERONE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE

FDA 510(k)

FDA Class 2 ·Ophthalmic

PEREGRINE WIDE ANGLE LIGHT PIPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

RMI TRANSILLUMINATOR, MODEL 292

FDA 510(k)

FDA Class 2 ·Ophthalmic

DSL ACTIVE ALDOSTERONE (DSL 8600)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RMI TRANSILLUMINATION LIGHT METER #295

FDA 510(k)

FDA Class 2 ·Ophthalmic

125I-ALDOSTERONE RIA DIAG. KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FIBEROPTIC ILLUMINATED INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

DSL ACTIVE ALDOSTERONE RIA (DSL 8600)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTERS VALVED GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MECHANICAL HEART VALVE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SJM ISOFLEX OPTIM LEADS

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·Neuropace RNS System

Tuttnauer Steam Sterilizer

FDA registration

Tuttnauer Kft.·1 product·🇭🇺 Hungary

BrainsWay Deep TMS System for Treatment of Major Depressive Disorder (MDD) (Model 104)

FDA registration

BRAINSWAY LTD.·1 product·🇮🇱 Israel