CalcShift™ Displacement Calcaneal Osteotomy System

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOPEDIATRICS BLADE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Care Team Portal

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

superDimension Navigation System V7.2

FDA 510(k)

FDA Class 2 ·Radiology

EMBOGUARD Balloon Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

PTFE PORTABLE INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

InCore TMT System

FDA 510(k)

FDA Class 2 ·Orthopedic

NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

FDA 510(k)

FDA Class 2 ·Ophthalmic

M-50 SERIES SPO2 SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

WRIST PULSE OXIMETER MD300W

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC

FDA 510(k)

FDA Class 2 ·Neurology

MICRUS MICROCATHETER, MODEL COURIER 270

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4

FDA 510(k)

FDA Class 2 ·Neurology

MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF

FDA 510(k)

FDA Class 2 ·Neurology

MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR

FDA 510(k)

FDA Class 2 ·Neurology

MICRUS COURIER MICROCATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular