16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AT 030
FDA 510(k)
FDA Class 2
·Ophthalmic
ECHELON GRAY CARTRIDGE, MODEL ERC45M
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BARIREP
FDA 510(k)
FDA Unclassified
·Unknown
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 5, 2023
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 20, 2013
UNKNOWN CHEST DRAINAGE SYSTEM
FDA Adverse Event
Death
·TELEFLEX MEDICAL·Product code KDQ·July 21, 2011
ROTATABLE SNARE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FDI·September 23, 2008
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 5, 2022
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 29, 2022
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019