SYNAPSE 3D CARDIAC TOOLS

FDA 510(k)

FDA Class 2 ·Radiology

Synapse Cardiovascular

FDA 510(k)

FDA Class 2 ·Radiology

OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SupaChair Powered Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP

FDA 510(k)

FDA Class 2 ·Physical Medicine

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

FDA 510(k)

FDA Class 2 ·Ophthalmic