8 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tandem Mobi insulin pump with interoperable technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Nitrile Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
FDA 510(k)
FDA Class 2
·Dental
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008
SECURE ACUTE CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 25, 2011
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·July 18, 2013
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025