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

Alizarin Sulfonate, Calcium

FDA classification

FDA Class 2 ·Alizarin Sulfonate, Calcium

Bacillus Subtilis Microbiology Assay, Tobramycin

FDA classification

FDA Class 2 ·Bacillus Subtilis Microbiology Assay, Tobramycin

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

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

FDA Pre-Market Approval

FDA Class 2 ·ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·COBAS INTEGRA 400 PLUS CYCLOSPORINE

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·PRO-TRAC II TACROLIMUS ELISA KIT