ImmersiveView Surgical Plan (IVSP®)

FDA 510(k)

FDA Class 2 ·Dental

ImmersiveTouch

FDA 510(k)

FDA Class 2 ·Radiology

PROSTHETIC RINGS #4400 MITRAL & 4500

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BK-N SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORFLO 300 PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III

FDA 510(k)

FDA Class 2 ·Cardiovascular

ETP 180 CARDIAC PACEMAKER (EXTERNAL)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·NDS LENS MAINTENANCE SYSTEM

SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE SURGICAL MASK (MODIFIED)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DUOSTAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

XPERCT REL. 3

FDA 510(k)

FDA Class 2 ·Radiology

Ingenia Elition and MR 7700 MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

Philips IntelliSite Pathology Solution 5.1

FDA 510(k)

FDA Class 2 ·Pathology