INNOCURE IMRT FILTER (COMPENSATORS)

FDA 510(k)

FDA Class 2 ·Radiology

INJECTRA INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EnCor MRI Introducer Set, EnCor Probe Introducer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BI-DIRECTIONAL TUNNELER

FDA 510(k)

FDA Class 2 ·Cardiovascular

GIP/MEDI-GLOBE ERCP CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Reprocessed CS Diagnostic Electrophysiology Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

GlidePath Retro Long-Term Hemodialysis Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VACORA VACUUM ASSISTED BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VENAFLO II VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WavelinQ Plus EndoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Crosser iQ CTO Recanalization System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Breezing Med

FDA 510(k)

FDA Class 2 ·Anesthesiology

GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology