Blue Eye

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

4CIS® Marlin ACIF Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

14HQ901G-B

FDA 510(k)

FDA Class 2 ·Radiology

HANAROSTENT FASTTM Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HKT Anatomical Locking Trauma System

FDA 510(k)

FDA Class 2 ·Orthopedic

Smartlux Mini

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Oneday Implant Abutment

FDA 510(k)

FDA Class 2 ·Dental

STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)

FDA 510(k)

FDA Class 2 ·Orthopedic

Biogensis Implant System-Kisses

FDA 510(k)

FDA Class 2 ·Dental

ADX6000 Portable X-Ray System; iRayA6

FDA 510(k)

FDA Class 2 ·Radiology

ZeTTA PACS

FDA 510(k)

FDA Class 2 ·Radiology

ENDOSEAL MTA

FDA 510(k)

FDA Class 2 ·Dental

Fixone hybrid knotless anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

Dentis s-Clean Regular Abutment

FDA 510(k)

FDA Class 2 ·Dental

JASPER Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

RFMagik Lite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LOSPA II Knee System (EXULT Knee Replacement System)

FDA 510(k)

FDA Class 2 ·Orthopedic

NoCoding1 Plus Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Agnes

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery