NDO SURGICAL SURGICAL OVERTUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACKRAD N-DO VAGE TUBE

FDA 510(k)

FDA Class 2 ·General Hospital

ENDOSCOPIC PLICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAXIMUS 3.0 AND OS IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

DualCap

FDA 510(k)

FDA Class 2 ·General Hospital

INTEGRA MOZAIK AND OS MOLDABLE MORSELS

FDA 510(k)

FDA Class 2 ·Orthopedic

NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO

FDA 510(k)

FDA Class 2 ·Radiology

Annabella Double Breast Pump (ADO-US23-1000)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMPROVACUTER GEL & CLOT ACTIVATOR TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius System 100 and GI Genius System 200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology