INSTANT-VIEW PREGNANCY URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INSTANT-VIEW MARIJUANA URINE CASSETTE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

MAURICE WORLDWIDE SHUNT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

SYSMEX SE/RAM-1

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX CA-1000/SYSMEX CA-5000

FDA 510(k)

FDA Class 2 ·Hematology

AIRO Suction Unit (AIRO-01)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XP TECHNOLOGY ULTRASONIC SCALER

FDA 510(k)

FDA Class 2 ·Dental

EZTEST-GAS

FDA 510(k)

FDA Class 2 ·General Hospital

LINSCAN 808, LINSCAN 980

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology