binx health io CT/NG Assay

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROSURGE LASER FIBER WITH SMA CONNECTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE FIBER OPTIC DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PULPDENT GLAZE

FDA 510(k)

FDA Class 2 ·Dental

TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES

FDA 510(k)

FDA Class 2 ·Orthopedic

AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNICATH SP BI-PLANE (MODEL M269 & M289)

FDA 510(k)

FDA Class 2 ·Radiology

ExSpiron 2Xi

FDA 510(k)

FDA Class 2 ·Anesthesiology

G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)

FDA 510(k)

FDA Class 2 ·Orthopedic

VIPER SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

ZOLL EPCR IOS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Omnipod GO Insulin Delivery Device

FDA 510(k)

FDA Class 2 ·General Hospital

FLOW-RITE

FDA 510(k)

FDA Class 2 ·Dental

ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD

FDA 510(k)

FDA Class 2 ·Dental

Instylla Microcatheter 1.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

MITEK PDS/PGA STAPLE

FDA 510(k)

FDA Class 2 ·Orthopedic