GAP ENDO-EXO MEDULLARY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GAP ENDO-EXO MEDULLARY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CARIOLINE(ELECTROCARDIOGRAPH)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001

FDA 510(k)

FDA Class 2 ·Microbiology

AI Platform 2.0 (AIP002)

FDA 510(k)

FDA Class 2 ·Radiology

Strain AI (SAI001)

FDA 510(k)

FDA Class 2 ·Radiology

CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMOCLAV VENOUS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Bladder AI (AIBV01)

FDA 510(k)

FDA Class 2 ·Radiology

AI Platform (AIP001)

FDA 510(k)

FDA Class 2 ·Radiology

Lung AI (LAI001)

FDA 510(k)

FDA Class 2 ·Radiology

PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

BonOs® Inject Bone Cement; NEO Pedicle Screw System™

FDA 510(k)

FDA Class 2 ·Orthopedic

NEO DENTA ZIRCONIA

FDA 510(k)

FDA Class 2 ·Dental

ENDOSCOPIC PLICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology