9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Universal Endometrial Applicator Set (GM11009840)
FDA 510(k)
FDA Class 2
·Radiology
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Novapak Nasal Sinus Packing and Stent
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
ULTRACISION HARMONIC SCALPEL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code LFL·November 10, 2008
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 19, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025