WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EaseVRx

FDA 510(k)

FDA Class 2 ·Neurology

Stanza

FDA 510(k)

FDA Class 2 ·Neurology

T2CANDIDA AND T2DX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SmartFlow Neuro Cannula

FDA 510(k)

FDA Class 2 ·Neurology

SureTune4 Software

FDA 510(k)

FDA Class 2 ·Neurology

Cala ONE

FDA 510(k)

FDA Class 2 ·Neurology

VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)

FDA 510(k)

FDA Class 2 ·Microbiology

GeneSTAT.MDx Coccidioides Assay

FDA 510(k)

FDA Class 2 ·Microbiology

ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

FDA 510(k)

FDA Class 2 ·Microbiology

Fibresolve

FDA 510(k)

FDA Class 2 ·Radiology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Acumen Hypotension Prediction Index (HPI) Feature Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFLOW INTRAURETHRAL VALVE-PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AeroForm Tissue Expander System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BREASTVIEW VISUAL MAPPING SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

vPatch

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NaviCam ProScan

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology