8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
FDA 510(k)
FDA Class 2
·Cardiovascular
Reprocessed Marinr Diagnostic EP Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
STAT KIT, MICROPROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code HTJ·June 18, 2014
ALCON
FDA Adverse Event
Other
·ALCON LABORATORIES, INC.·Product code LZS·October 19, 2010
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·December 20, 2012
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
FDA Enforcement
Class I
·Ongoing·B. Braun Medical, Inc.·November 1, 2023
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020