9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
FDA 510(k)
FDA Unclassified
·Unknown
PEN NDL 31G 5MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·October 11, 2019
EZ-OX PLUS GENERATION II
FDA 510(k)
FDA Class 1
·Anesthesiology
LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX
FDA 510(k)
FDA Class 1
·General Hospital
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 18, 2011
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025