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

SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

QUANTA LITE ACA IGM (HRP)

FDA 510(k)

FDA Class 2 ·Immunology

VIEW NT

FDA 510(k)

FDA Class 2 ·Radiology

VIEW COM

FDA 510(k)

FDA Class 2 ·Radiology

VIEW ARCHIVING STATION

FDA 510(k)

FDA Class 2 ·Radiology

VIEW READING STATION

FDA 510(k)

FDA Class 2 ·Radiology

Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery