16 results · 25ms · Sources: EU EUDAMED, 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