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Subcutaneous Lead

FDA registration
Medtronic Bakken Research Center B.V. (BRC)·2 products·🇳🇱 Netherlands

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

PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

MP/S SINGLE WAVELENGTH MINI PHOTOMETER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ADVIA CENTAUR TESTOSTERONE (TSTO)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

EXEL BUTTERFLY SCALP VEIN SET

FDA 510(k)
FDA Class 2 ·General Hospital

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

MP MINI PHOTOMETER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HBM HEMOGLOBINOMETER

FDA 510(k)
FDA Class 2 ·Hematology

Terumo Pump Tubing

FDA 510(k)
FDA Class 2 ·Cardiovascular

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

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