TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Focus Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

GE CT/T MODEL NO. B7800 A

FDA 510(k)

FDA Class 2 ·Radiology

PALMLIGHT

FDA 510(k)

FDA Class 2 ·Dental

Revitive IX (OTC)

FDA 510(k)

FDA Class 2 ·Physical Medicine