10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPINSEP-TBG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHRON® AMYLASE (AMY) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JFJ·September 21, 2010
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·April 30, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·December 3, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·October 16, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 21, 2013
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 31, 2014
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·January 27, 2011