BioFire Joint Infection (JI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Eroxon

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WallFlex Biliary RX Fully Covered Stent System RMV

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Phagenyx System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))

FDA 510(k)

FDA Class 2 ·Cardiovascular

Orthobond Mariner Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

XSTAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Breast Implant Removal Device (BIRD)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ConcizuTrace™ ELISA

FDA 510(k)

FDA Class 2 ·Hematology

DuraGraft

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

RETROX

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

t:slim X2 insulin pump with interoperable technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEM-AVERT PERIANAL STABILIZER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

gammaCore Non-invasive Vagus Nerve Stimulator

FDA 510(k)

FDA Class 2 ·Neurology

PrimeStore MTM

FDA 510(k)

FDA Class 2 ·Microbiology

reSet

FDA 510(k)

FDA Class 2 ·Neurology

NUCLEUS-X PTV CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND

FDA 510(k)

FDA Class 2 ·Neurology