Focus Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADVIA Centaur Enhanced Liver Fibrosis (ELF)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Aurora

FDA 510(k)

FDA Class 2 ·Radiology

Omni Legend

FDA 510(k)

FDA Class 2 ·Radiology

TECHNICON FAST-LC SYS. ANTICONVU DRUGS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology