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

IVYLASER Diode laser hair removal system (IVY-HR-Alloy)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

LELTEK Ultrasound Imaging System (Model: LU700 Series)

FDA 510(k)

FDA Class 2 ·Radiology

FEMME Applicator Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Franz Zirconia Dental Crown

FDA 510(k)

FDA Class 2 ·Dental

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

IVYLASER Handhold Hair Removal Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry