PRO-LINE CT (BASIC TRAY) MODEL MR28036101

FDA 510(k)

FDA Class 2 ·General Hospital

syngo.CT Lung CAD

FDA 510(k)

FDA Class 2 ·Radiology

AMICI XENON REBREATHING SYSTEM*

FDA 510(k)

FDA Class 2 ·Radiology

ENNOVATE®

FDA 510(k)

FDA Class 2 ·Orthopedic

LARGE BORE SPLITTABLE INTRODUCER KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Modulift Vertebral Body Replacement (VBR) System

FDA 510(k)

FDA Class 2 ·Orthopedic

MRINNERVU ENDORECTAL PROSTATE COIL

FDA 510(k)

FDA Class 2 ·Radiology

SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)

FDA 510(k)

FDA Class 2 ·Anesthesiology

ONO Retrieval Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNTHES CRANIAL PLATES

FDA 510(k)

FDA Class 2 ·Dental

FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD

FDA 510(k)

FDA Class 2 ·Cardiovascular

B. BRAUN BICARBONATE DIALYSATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDRAD Imaging Bulk Package Transfer Spike

FDA 510(k)

FDA Class 2 ·General Hospital

Waypoint GPS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

STELKAST BIPOLAR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DYTRACT FLOW RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T

FDA 510(k)

FDA Class 2 ·General Hospital

DYNACT

FDA 510(k)

FDA Class 2 ·Radiology