ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACE Hemoglobin A1c (HbA1c) Reagent

FDA 510(k)

FDA Class 2 ·Hematology

MAXAN ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ARROW-LOK DIGITAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INTEL-GE CARE INNOVATIONS CONNECT RCM

FDA 510(k)

FDA Class 2 ·Cardiovascular

H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

LUTH-ALL SUB-Q NEEDLE SET

FDA 510(k)

FDA Class 2 ·General Hospital

Progressive Orthopaedic Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

SPECTRUM SPINE SPINOUS PROCESS DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

MLP Special Locking Bone Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

LASERBRUSH

FDA 510(k)

FDA Class 2 ·Physical Medicine

SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

ToeTac™ 10° Hammertoe Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Sourcerer

FDA 510(k)

FDA Class 2 ·Neurology

SIGNA Architect

FDA 510(k)

FDA Class 2 ·Radiology

CrossTie Intraosseous Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Climax Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CrossRoads Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

JETPOLISHER(TM)

FDA 510(k)

FDA Class 2 ·Dental

HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology