BraidE Embolization Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Temporary Embolization Assist Device, Peripheral

FDA classification

FDA Class 2 ·Temporary Embolization Assist Device, Peripheral

CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS

FDA 510(k)

FDA Class 2 ·Radiology

OREAI-Q-TU TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QCU ANALYTICAL SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

CTS-200 WITH EZU-PL21 TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

FDA 510(k)

FDA Class 2 ·Dental

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE® THC Urine Strip Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Powered Muscle Stimulator (Model name:MagGraver F200)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ancora Nerve Block Catheter Set

FDA 510(k)

FDA Class 2 ·Anesthesiology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Pelvic Floor Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SNAZZY2

FDA 510(k)

FDA Class 2 ·Physical Medicine

MetaLite DX Digital Pathology Software

FDA 510(k)

FDA Class 2 ·Pathology