GC E-LIGHT

FDA 510(k)

FDA Class 2 ·Dental

Focus Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GCE Zen-O Portable Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA CATHETER

PQ1

FDA 510(k)

FDA Class 2 ·Dental

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

FDA 510(k)

FDA Class 2 ·Microbiology

Atellica IM High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Enhanced Liver Fibrosis (ELF)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MDI MII ONE-PIECE IMPLANT, 2.9MM

FDA 510(k)

FDA Class 2 ·Dental

CLINICAL ALERT NOTIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVIA Centaur TSH3-Ultra

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA CENTAUR FT4, ADVIA CENTAUR T4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Toxoplasma M (Toxo M)

FDA 510(k)

FDA Class 2 ·Microbiology

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACE(TM) AND LONG ACE(TM) MODELS

ROSE K POST GRAFT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ZenPro 40

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED ACE(TM)&LONG ACE(TM)PTCA CATHETERS

ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic