10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LZI Fentanyl Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493929757·AVANOS* Universal Block Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651929751·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974032·UniTip High Resolution Catheter 12F
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 21, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·September 30, 2008
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021