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

QUANTA FLASH (TM) DGP SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

Resolve 2.0

FDA 510(k)

FDA Class 2 ·Dental

NUVASIVE MASH

FDA 510(k)

FDA Class 2 ·Orthopedic

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NUVASIVE NEUROVISION JJB SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

QUANTA LITE SS-A 52 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC

FDA 510(k)

FDA Class 2 ·Neurology