12 results
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19ms
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Sources: EU EUDAMED, US FDA
MINIVAGE(R)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KONG-TL VBR E, Expandable Body, Standalone, XXS, Ø 19 mm x 19 - 23 mm
FDA UDI
icotec AG·07640164847405·KONG-TL VBR E, Expandable Body, Standalone, XXS...
Elos Accurate Hybrid Base
FDA 510(k)
FDA Class 2
·Dental
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
FDA 510(k)
FDA Class 2
·Immunology
MELODY TRANSCATHETER PULMONARY VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·November 16, 2018
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2014
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 11, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 24, 2010
FARAWAVE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·November 10, 2025
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·June 7, 2022
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
FDA Enforcement
Class II
·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·August 14, 2024
3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010