SCX SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SCX INFORMATION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

IVD CAPSULE PSP; abioSCOPE

FDA 510(k)

FDA Class 2 ·Microbiology

Immunoassay For Host Biomarkers Of Sepsis

FDA classification

FDA Class 2 ·Immunoassay For Host Biomarkers Of Sepsis

COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

GRAFTCAGE ACX

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Lorals

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLYDE DAM LOLLYES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Harmony Latex Dam, Harmony Non-Latex Dam

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TRUST DAM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SHEER GLYDE DAMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SancDam Latex Oral Dam

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACX RX COMET VP CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HARTZLER ACX II(R) CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS HARTZLER ACX II CORONARY DILATATION BALLOON CA

SUPER SEAL TOOTH DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

DISCOVRED

FDA 510(k)

FDA Class 2 ·Dental

Flyte

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology