28 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COTRONIC DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
Oticon
FDA UDI
Oticon A/S·05707131167521·ACTO, ITC P PB L BE
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
PLATEAU-TL
FDA UDI
Life Spine, Inc.·00190837028756·PLATEAU-TL Interbody, Convex, Bulleted, 10mm x ...
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964094101·Trial Procedure Kit
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964095153·Endo Carry-On Procedure Kit
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964107580·Endo Carry-On Procedure Kit
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964096549·Endo Carry-On Procedure Kit
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964093548·Trial Procedure Kit
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964093562·Trial Procedure Kit
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964107573·Endo Carry-On Procedure Kit
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964110764·Custom Procedure Kit
AT HOME DRUG TEST, MODEL 9084
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)
FDA 510(k)
FDA Class 2
·Dental
BD MAX¿ ENTERIC PARASITE PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·March 28, 2022
CONTOUR PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024
CONTOUR PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011