12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
FDA 510(k)
FDA Class 2
·Microbiology
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032606·microSelectron Coupling Transfer Tube (9)
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089448807·
ECO SUPERGEL
FDA 510(k)
FDA Class 2
·Radiology
MODEL 100 ACTIVITY MONITOR
FDA 510(k)
FDA Class 2
·Neurology
HANDLE CEV1039-5-B DIA 5MM ANG [MXI/XOM]
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code GEI·May 14, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 23, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 2, 2011
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025