BinaxNOW COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

DOPPLER NEEDLE AND FLOW MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

OsteoFab Patient Specific Facial Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACTICLOT, MODEL 824

FDA 510(k)

FDA Class 2 ·Hematology

PSG(TM) 20 GUAGE DOPPLER NEEDLE

FDA 510(k)

FDA Class 2 ·Radiology

EDM(R) INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITAACCESS CATHETER INTRODUCER KIT

FDA 510(k)

FDA Class 2 ·General Hospital

BinaxNOW™ COVID-19 Antigen Self Test; BinaxNOW™ COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

SpineFab Vertebral Body Replacement (VBR) System

FDA 510(k)

FDA Class 2 ·Orthopedic

LOBOW

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVANCE 418(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PSG(TM) EDM(TM) INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCESSOR PERIPHERAL DILATING GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TSI WILLEN-REICH NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology