STOPWET iontophoresis apparatus (SW01)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Xpert Xpress Strep A

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

FDA 510(k)

FDA Class 2 ·Microbiology

Axonpen, Axonmonitor, Axonbox, Tablet

FDA 510(k)

FDA Class 2 ·Neurology

Synapse 3D Liver and Kidney Analysis

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert CT/NG

FDA 510(k)

FDA Class 2 ·Microbiology

SATURN 8000

FDA 510(k)

FDA Class 2 ·Radiology

MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

COTRONIC DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

SYNAPSE 3D CARDIAC TOOLS

FDA 510(k)

FDA Class 2 ·Radiology

Synapse Cardiovascular

FDA 510(k)

FDA Class 2 ·Radiology

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