53 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD Horizon Spinal System
FDA 510(k)
FDA Class 2
·Neurology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022687·Dornier 600 µm Single-Use SMA Diode Laser Fiber...
TOTAL SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UREA NITROGEN (BUN) LIQUID REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 31, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 27, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 19, 2026
UNICEL DXI ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·October 29, 2014
SPACELABS ULTRAVIEW SL COMMAND MODULE
FDA Adverse Event
Death
·SPACELABS MEDICAL INC.·Product code DSI·July 8, 2013
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 8, 2026
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 4, 2026
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 2, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·July 31, 2025
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·November 10, 2025
ALINITY I TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·July 14, 2025
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 18, 2025
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 13, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·February 9, 2026