10 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONET Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ELMED
FDA UDI
ELMED INCORPORATED·00842180135444·3 MM DIA., 33 CM INSULATED NEEDLE ELECTRODE, SI...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306824531·Walther Female Dilator-Catheters 13cm, 34Fr
INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIVA EB
FDA 510(k)
FDA Class 2
·Anesthesiology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 24, 2020
ACF DISTRACTION SCREW 12MM ONE
FDA Adverse Event
Malfunction
·INSTRUMED INTERNATIONAL·Product code MQP·November 3, 2008
ALLURA XPER FD10
FDA Adverse Event
Death
·PHILIPS HEALTHCARE·Product code IZI·August 16, 2011
DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025