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

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Self-Fitting hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sontro® OTC Hearing Aids (AI)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Eargo 5 , Eargo 6

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Intrisound™ Tuned Lumen® 155 Hearing Aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Concha Sol Hearing Aids (CL-1001)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WSA Self-Fitting Hearing Aid Gen 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Nuheara IQbuds 2 PRO Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II ASSAY