10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARIA RADIATION THERAPY MANAGEMENT
FDA 510(k)
FDA Class 2
·Radiology
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K133552621·ELATION® MB Base Rx 022 UL/5-5 CS-BC HK
INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·October 29, 2025
K133532
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·February 2, 2021
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2026
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 29, 2013
JETSTREAM G3
FDA Adverse Event
Injury
·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·June 16, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 22, 2008