AST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO L-TYPE GOT TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT ARCHITECHT AFP

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX AFP ASSAY

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP (LIST 7A48)

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-E AFP