13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXACTECH GPS
FDA 510(k)
FDA Class 2
·Neurology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508895·
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 9, 2024
DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·May 3, 2016
DIACAP ULTRA DIALYSIS FLUID FILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESOLUTION II CLIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 4
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·May 3, 2016
DURAGEN PLUS DURAL REGENERATION MATRIX 3X3 5 PAC
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·May 3, 2016
CELL-DYN RUBY ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·October 8, 2014
CARELINK
FDA Adverse Event
Malfunction
·TRIVIRIX MINNEAPOLIS·Product code NVZ·June 8, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021