CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pump, Infusion, Pca

FDA classification

FDA Class 2 ·Pump, Infusion, Pca

Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

XPERCT REL. 3

FDA 510(k)

FDA Class 2 ·Radiology

Ingenia Elition and MR 7700 MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

Philips IntelliSite Pathology Solution 5.1

FDA 510(k)

FDA Class 2 ·Pathology

Brain Perfusion (BP) application

FDA 510(k)

FDA Class 2 ·Radiology

16 Breast Coil

FDA 510(k)

FDA Class 2 ·Radiology

Philips IntelliSite Pathology Solution

FDA 510(k)

FDA Class 2 ·Pathology

Ingenia 1.5T CX and Ingenia 3.0T CX R5.3

FDA 510(k)

FDA Class 2 ·Radiology

Philips IntelliSite Pathology Solution

FDA 510(k)

FDA Class 2 ·Pathology

Brain Perfusion (BP) application

FDA 510(k)

FDA Class 2 ·Radiology

MR 5300 and MR 7700 R11 MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

MECHANICAL WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

2D PERFUSION

FDA 510(k)

FDA Class 2 ·Radiology