dermalux Flex MD

FDA 510(k)

FDA Class 2 ·Physical Medicine

iCOquit® Smokerlyzer®

FDA 510(k)

FDA Class 2 ·Anesthesiology

SURGISILK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEPILASE TWIN YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAXIFLO, TAPERFLO

FDA 510(k)

FDA Class 2 ·Cardiovascular

FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ODFS Pace XL

FDA 510(k)

FDA Class 2 ·Neurology

E.P.T. PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Unifine SafeControl

FDA 510(k)

FDA Class 2 ·General Hospital

ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PICO Single Use Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEMPUS IC PROFESSIONAL PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

FDA 510(k)

FDA Class 2 ·Immunology

P200TE (A10700)

FDA 510(k)

FDA Class 2 ·Ophthalmic

ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ULTIMA TENS XL-A1

FDA 510(k)

FDA Class 2 ·Neurology

RANDOX RX DAYTONA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001

FDA 510(k)

FDA Class 2 ·Radiology