COE SOFT

FDA 510(k)

FDA Class 2 ·Dental

COE COMFORT

FDA 510(k)

FDA Class 2 ·Dental

EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FASTEP S10 HCG SERUM/URINE COMBO TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COE-SOFT LC

FDA 510(k)

FDA Class 2 ·Dental

AQUACISER II

FDA 510(k)

FDA Class 2 ·Physical Medicine

COE-LITE POLYMERIZATION UNIT

FDA 510(k)

FDA Class 2 ·Dental

HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE

FDA 510(k)

FDA Class 2 ·Anesthesiology

PQ1

FDA 510(k)

FDA Class 2 ·Dental

EVOS Pelvic and Acetabular System

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOS Patella Plates

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOLOX DELTA CERAMIC FEMORAL HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic

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

SMITH & NEPHEW HIP SYSTEMS WITH HA

FDA 510(k)

FDA Class 2 ·Orthopedic

Atellica IM High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY

FDA 510(k)

FDA Class 2 ·Cardiovascular

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