OverStitch NXT Endoscopic Suturing System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GROSHONG NXT DUAL LUMEN PICC CATHETERS

FDA 510(k)

FDA Class 2 ·General Hospital

Agilis NxT Steerable Introducer Dual-Reach

FDA 510(k)

FDA Class 2 ·Cardiovascular

AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM G2 NXT SYSTEM, MODEL PV20300

FDA 510(k)

FDA Class 2 ·Cardiovascular

THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323

FDA 510(k)

FDA Class 2 ·Cardiovascular

Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever

FDA 510(k)

FDA Class 2 ·Neurology

Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™

FDA 510(k)

FDA Class 2 ·Cardiovascular

XENON DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CIMILRE Free-T2 Plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AXT 150M MANUAL COLLIMATOR (AXT 150M)

FDA 510(k)

FDA Class 2 ·Radiology

ASTOFLO

FDA 510(k)

FDA Class 2 ·Hematology

DENTORIUM CONVERTIBLE ACRYLIC

FDA 510(k)

FDA Class 2 ·Dental

VERTIFORM POSTERIOR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDVIZER PACS, MODEL RELEASE 2000

FDA 510(k)

FDA Class 2 ·Radiology