ExactechGPS® Total Ankle Application

FDA 510(k)

FDA Class 2 ·Neurology

ResCUBE™ Ligament Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LEONI ORION System

FDA 510(k)

FDA Class 2 ·Radiology

Insulia Diabetes Management Companion

FDA 510(k)

FDA Class 2 ·Anesthesiology

SQUALE

FDA 510(k)

FDA Class 2 ·Orthopedic

EndoSize

FDA 510(k)

FDA Class 2 ·Radiology

Maestro System (REF100)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NasalCEASE and BleedCEASE

FDA 510(k)

FDA Unclassified ·Unknown

PASS LP SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

FDA 510(k)

FDA Class 2 ·Orthopedic

IMPLANTEO IMPLANTOLOGY MOTOR

FDA 510(k)

FDA Class 1 ·Dental

Activmotion S DTO

FDA 510(k)

FDA Class 2 ·Orthopedic

FT4 RADIOIMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Liver Suite

FDA 510(k)

FDA Class 2 ·Radiology

Aequalis Fx2

FDA 510(k)

FDA Class 2 ·Orthopedic

V-STRUT Vertebral Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

TROPHYPAN

FDA 510(k)

FDA Class 2 ·Dental

TORNIER TOTAL ELBOW PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic