CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PASS OCT Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems

FDA 510(k)

FDA Class 2 ·Radiology

CANNULATED SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

STERISPINE LC CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

SenoBright HD

FDA 510(k)

FDA Class 2 ·Radiology

ALN OPTIONAL VANA CAVA FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ETEST Fosfomycin (FO) (0.032-512 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

F-400 SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5

FDA 510(k)

FDA Class 2 ·Orthopedic

Insulia Diabetes Management Companion

FDA 510(k)

FDA Class 2 ·Anesthesiology

Pristina Serena

FDA 510(k)

FDA Class 2 ·Radiology

AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232

FDA 510(k)

FDA Class 1 ·Dental

NEUROMATE FRAMELESS GEN II

FDA 510(k)

FDA Class 2 ·Neurology

Hexanium® ACIF

FDA 510(k)

FDA Class 2 ·Orthopedic

FibroScan

FDA 510(k)

FDA Class 2 ·Radiology

DCX Disposable Cassette (DCX)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIDAS LYME IGM

FDA 510(k)

FDA Class 2 ·Microbiology

DENSEEMAMMO v1.0

FDA 510(k)

FDA Class 2 ·Radiology

STERISPINE LC CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic