MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SATURN 8000-GS

FDA 510(k)

FDA Class 2 ·Radiology

Synapse PACS

FDA 510(k)

FDA Class 2 ·Radiology

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System

FDA 510(k)

FDA Class 2 ·Microbiology

VCS S3T

FDA 510(k)

FDA Class 2 ·Physical Medicine

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

FDA 510(k)

FDA Class 2 ·Microbiology

MAMMOGRAPHY VIEWER SMV658

FDA 510(k)

FDA Class 2 ·Radiology

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

VCS, MODEL S4T

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0

FDA 510(k)

FDA Class 2 ·Radiology

SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS

FDA 510(k)

FDA Class 2 ·Radiology

THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

RIGID GAS PERMEABLE CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MENICON SF-P

FDA 510(k)

FDA Class 2 ·Ophthalmic

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic