IMPLANET Spine System (ISS)

FDA 510(k)

FDA Class 2 ·Orthopedic

IB3D™ PL Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMILERS

FDA 510(k)

FDA Class 2 ·Dental

ROSA ONE Brain application

FDA 510(k)

FDA Class 2 ·Neurology

CT Perfusion V1.0

FDA 510(k)

FDA Class 2 ·Radiology

SOFAMOR ORFIL SPINE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Exciplex308nm

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)

FDA 510(k)

FDA Class 2 ·Hematology

EXACTECH GPS

FDA 510(k)

FDA Class 2 ·Neurology

BI-MENTUM dual mobility system

FDA 510(k)

FDA Class 2 ·Orthopedic

TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK

FDA 510(k)

FDA Class 2 ·Neurology

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Knee+

FDA 510(k)

FDA Class 2 ·Neurology

PuraStat

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03

FDA 510(k)

FDA Class 2 ·Cardiovascular

MR DWI/FLAIR Measurement V1.0

FDA 510(k)

FDA Class 2 ·Radiology

CINA-iPE

FDA 510(k)

FDA Class 2 ·Radiology

Thoracic VCAR with GSI Pulmonary Perfusion

FDA 510(k)

FDA Class 2 ·Radiology

L720 EXAMINATION CHAIR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology