APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1

FDA 510(k)

FDA Class 2 ·Immunology

Perfetta Moderate Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WAKO AUTOKIT APO B

FDA 510(k)

FDA Class 2 ·Immunology

APO-Easy Genotyping kit

FDA 510(k)

FDA Class 2 ·Immunology

APO-TEK LP(A)

FDA 510(k)

FDA Class 2 ·Immunology

APOLIPOPROTEIN CALIBRATOR (APO-CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

K-ASSAY APO AI

FDA 510(k)

FDA Class 2 ·Immunology

K-ASSAY APO B

FDA 510(k)

FDA Class 2 ·Immunology

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10

FDA 510(k)

FDA Class 2 ·General Hospital

FemDx FalloView

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INFRARED THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGABLE BRAIN BIOPSY CANNULA SET

FDA 510(k)

FDA Class 2 ·Neurology

Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VUE 100 ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Upper Arm Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular