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

DMS-1000C DERMOABRADER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

DERMABRADER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

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

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

CLINICAL ALERT NOTIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVIA Centaur TSH3-Ultra

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PATIENT EXAMINATION GLOVEWS

FDA 510(k)

FDA Class 1 ·General Hospital

ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ADVIA CENTAUR FT4, ADVIA CENTAUR T4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry