10 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Implants and Abutments
FDA 510(k)
FDA Class 2
·Dental
SPINA SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
DIGORA OPTIME
FDA 510(k)
FDA Class 2
·Dental
PUMP MMT-1884 MM780G MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 17, 2025
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·October 23, 2024
STAPLE, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 6, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 2, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·September 21, 2020
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024