9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TINA-QUANT CRP
FDA 510(k)
FDA Class 2
·Immunology
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029045725·LO UNIV 1st BI NO HK
BROADMASTER HEALTHCARE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ATAC CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 28, 2013
OSTEOTOME GUARDED 180MM STR CLAOUE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INSTRUMENTS·Product code LRC·December 16, 2010
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 12, 2014
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Enforcement
Class II
·Ongoing·Barco N.V.·July 2, 2025
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Recall
Open, Classified
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 2025