7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITA TITANIUM PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
FDA 510(k)
FDA Class 2
·Cardiovascular
FiXcision
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 16, 2014
MINILAP ALLIGATOR GRASPER
FDA Adverse Event
Injury
·STRYKER·Product code LXH·February 21, 2013
ARTELON CMC SPACER
FDA Adverse Event
Injury
·ARTIMPLANT AB·Product code KYI·February 2, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024