AQUARIUS EXTENSION FEEDING SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stylus

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PQ1

FDA 510(k)

FDA Class 2 ·Dental

Dental Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)

FDA 510(k)

FDA Class 2 ·Microbiology

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

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Versant HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)