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

TEAR VOLUME TESTS

FDA 510(k)

FDA Class 1 ·Ophthalmic

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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·TRIFECTA VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·BIOCOR/EPIC VALVE

BICORE VARIFLEX(R) FLOW TRANSDUCER

FDA 510(k)

FDA Class 1 ·Anesthesiology

TECNOL O.R. TOURNIQUET COVER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

DRAGER ORM

FDA 510(k)

FDA Class 1 ·Anesthesiology

MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS

FDA 510(k)

FDA Class 1 ·Anesthesiology

KEITHLEY CLAMP

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery