8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Annalise Enterprise CXR Triage Pneumothorax
FDA 510(k)
FDA Class 2
·Radiology
PULSION FS LASER KERATOME
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 7, 2025
ARTICULEZE M HEAD 36MM - 2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·October 27, 2008
DUR MAR 10D LNR 32IDX52OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code LPH·August 12, 2011
STOCKERT 70 RF GENERATOR
FDA Adverse Event
Malfunction
·STOCKERT GMBH·Product code DRF·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019