11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD LUER LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·December 26, 2019
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
FDA 510(k)
FDA Class 2
·Dental
AART GLUTEAL IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code NVY·April 10, 2013
INNER SHAFT FOR EXTRACTION SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·September 2, 2014
VITALITY AVT
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
RD SET NEO CS-3
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018