26 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMBARINO High-Class
FDA 510(k)
FDA Class 2
·Dental
FASTIN ETHIBOND
FDA UDI
DEPUY MITEK, LLC·10886705008254·FASTIN RC Anchor with ETHIBOND Titanium Anchor ...
MASTEL 1 FOLDER IMPLANTATION SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
BTL-995-rTMS
FDA 510(k)
FDA Class 2
·Neurology
JDEVOLUTION PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYG·May 21, 2026
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·May 14, 2026
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·May 18, 2026
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 17, 2026
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 22, 2026
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 17, 2026
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·August 29, 2025
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 17, 2026
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·November 10, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
7.0MM CANNULATED SCREW 32MM THREAD/60MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 12, 2013
BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·March 16, 2016
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·August 8, 2025
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·December 1, 2025
SWAN-GANZ
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·December 24, 2025