Alere Afinion HbA1c, Alere Afinion AS100 Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

DISCOVERY MR750W 3.0T

FDA 510(k)

FDA Class 2 ·Radiology

Fractional CO2 Laser Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medical Picosecond ND: YAG Laser System (PZ-6)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Custom-made Invisible Aligners

FDA 510(k)

FDA Class 2 ·Dental

E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Diode Laser Body Sculpture Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Single-use medical face mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

G-ARM MULTISCAN SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Levator Elite (Model LE9011)

FDA 510(k)

FDA Class 2 ·Physical Medicine

JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

Migraine Tens Digital Pain Reliever

FDA 510(k)

FDA Class 2 ·Neurology