GENIE CUP INTEGRATED SCREENING DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

GLYCOSAL II HBA 1C TEST

FDA 510(k)

FDA Class 2 ·Hematology

WellDoc BlueStar

FDA 510(k)

FDA Class 2 ·General Hospital

VENNER TRACHEAL SEAL MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

SERIES SY DISPOSABLE ELECTROSURGICAL PAD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

TOPOGRAPHIC IMAGING MARKER

FDA 510(k)

FDA Class 2 ·Radiology

RADIFOCUS(R) (CATHETER) GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

XERON PACS

FDA 510(k)

FDA Class 2 ·Radiology

AMCAD-UT DETECTION MODEL 2.0

FDA 510(k)

FDA Class 2 ·Radiology

VISIONTOOL

FDA 510(k)

FDA Class 2 ·Radiology

FUTREX-5000A

FDA 510(k)

FDA Class 2 ·Cardiovascular

WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CYTOGUARD(R)

FDA 510(k)

FDA Class 2 ·General Hospital

ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

AccuPoint Electrode

FDA 510(k)

FDA Class 2 ·Neurology