16 results
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21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WHILL Model F
FDA 510(k)
FDA Class 2
·Physical Medicine
INSEMINATION CATHETER, MODEL 320301
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
FDA 510(k)
FDA Class 2
·Microbiology
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·August 12, 2025
CAPTURE-R READY-SCREEN 3
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·January 8, 2010
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 3, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 16, 2011
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 11, 2013
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 29, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 10, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 22, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·December 27, 2025
PSX INTERBODY SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·September 16, 2025