20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SmartSiteTM Vented Vial Access Device
FDA 510(k)
FDA Class 2
·General Hospital
Oticon
FDA UDI
Sbo Hearing A/S·05714464059331·Oticon Companion 1.0.0 iOS
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ufi Gel hard C
FDA 510(k)
FDA Class 2
·Dental
BD SUREPATH¿ COLLECTION VIAL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MKQ·March 1, 2023
GLP TRACK END
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 18, 2026
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 11, 2014
APEX MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·September 12, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 23, 2013
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·July 10, 2025
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 28, 2025
NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
GLP ALIQUOT MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·August 1, 2025
GLP TRACK END
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 1, 2026
GLP TRACK END
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·November 14, 2024
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·June 19, 2025
GLP BULK LOADER MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 12, 2025
GLP LOADER MODULE
FDA Adverse Event
Injury
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 5, 2025