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

THE OPTIC BOX CONTACT LENS CASE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SCB/STERIS OR-LIGHT INTERFACE BOX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASCENT XXL CLOSED BOX FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TubeClear Control Box and Clearing Stem

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PSG INPUT BOX, MODEL JE-912AK

FDA 510(k)

FDA Class 2 ·Neurology

ASCENT XXL OPEN BOX FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

ELECTRODE JUNCTION BOX, MODEL JE-921A

FDA 510(k)

FDA Class 2 ·Neurology

UVB LIGHT BOX - UVB LIGHT BOOTH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MASTERLAB PFT AND MASTERLAB BODY BOX

FDA 510(k)

FDA Class 2 ·Anesthesiology

URIC ACID (AOX), SCAL, NORTROL, ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry