CUSTOM PERSONAL EAR - CPE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

CPE 2000 CARDIO PULMONARY ERGOMETER

FDA 510(k)

FDA Class 1 ·Cardiovascular

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

PERFECT EAR PE/PE-AGC/PE-B/PE-PWR

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

MODEL 2721 CLINICAL REFRACTOMETER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODEL 3471 CLINICAL REFRACTOMETER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODEL 2730 CLINICAL REFRACTOMETER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODEL A300CL CLINICAL REFRACTOMETER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODEL 2740 CLINICAL REFRACTOMETER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODEL 3461 CLINICAL REFRACTOMETER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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

ADVIA CENTAUR TESTOSTERONE (TSTO)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MDI MII ONE-PIECE IMPLANT, 2.9MM

FDA 510(k)

FDA Class 2 ·Dental