24 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RayStation 7
FDA 510(k)
FDA Class 2
·Radiology
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896000292·FUKUSHIMA SUCTION TUBE
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991803790·FUKUSHIMA SUCTION TUBE
AIR-N-GO
FDA 510(k)
FDA Class 1
·Dental
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
FDA 510(k)
FDA Class 2
·Neurology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 24, 2022
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
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 27, 2011
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
POSEY SITTER ELITE
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·October 15, 2014
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
BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022