9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
FDA 510(k)
FDA Class 2
·Dental
RELION¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 5, 2018
CI../..X liner for NOVAE Dual Mobility Acetabular Cup
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXI-STAT SP02 EAR SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
TARGETING ARM PROX. LAT TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 11, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025