MSI MODEL S-500 RF GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VT·One, VT·One 60days

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MSI TA ELECTRODES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WAKO (TM) AUTOKIT GOT TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)

FDA 510(k)

FDA Class 2 ·Neurology

Gems Oocyte Retrieval Buffer ORB-20, ORB-50

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Geri Embryo Incubator and Geri Dish

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

“BRAXX” Esophageal Brachytherapy Applicator

FDA 510(k)

FDA Class 2 ·Radiology

Geri Embryo Incubator and Geri Dish

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MSI SA ELECTRODES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Cellvizio 100 Series System with Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cellvizio 100 Series System with Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cellvizio I.V.E. with Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology