BrainScope TBI (Model: Ahead 400)

FDA 510(k)

FDA Class 2 ·Neurology

MDHearingAid app, MDHearingAid Smart hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GSI SA60 DPOAE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ClearRead CT

FDA 510(k)

FDA Class 2 ·Radiology

EYE-SYNC

FDA 510(k)

FDA Class 2 ·Neurology

SPEECHLINK 100 TYPE 1053

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EyeBOX

FDA 510(k)

FDA Class 2 ·Neurology

COLON CAR 1.2

FDA 510(k)

FDA Class 2 ·Radiology

ER-7C CLINICAL PROBE MICROPHONE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

IMAGECHECKER CT CAD SOFTWARE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·DTU-ONE ULTRASOUND SCANNER

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

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

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE

WIDEXLINK IN CLEAR SERIES HEARING AIDS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000

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

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000D

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

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER