QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3

FDA 510(k)

FDA Class 2 ·Immunology

AURALAY PIT & FISSURE SEALANT

FDA 510(k)

FDA Class 2 ·Dental

QUANTA PLEX CELIAC IGG PROFILE

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA PLEX ANCA PROFILE

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMI-ARC SURGICAL NAVIGATOR

FDA 510(k)

FDA Class 2 ·Neurology

EYE SPHERES

FDA 510(k)

FDA Class 2 ·Ophthalmic

WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

NOVA Lite DAPI ANA Kit

FDA 510(k)

FDA Class 2 ·Immunology

LASER SHIELDING TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

TITANIUM HIP TOOL LOCKING PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

CATHETER INSERTION TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

Butterfly iQ/iQ+ Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Calcium Bridge

FDA 510(k)

FDA Class 2 ·Dental

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

STEALTH SURGICAL IRRIGATOR ASPIRATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIMPEX INC. ORAL AND RECTAL THERMOMETERS

FDA 510(k)

FDA Class 2 ·General Hospital