16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADAPTER-Y TYPE/CORONARY PERFUSION
FDA 510(k)
FDA Class 2
·Cardiovascular
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
FDA 510(k)
FDA Unclassified
·Unknown
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 5, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2010
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
ULTRATHANE SUPRAPUBIC CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KOB·August 23, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·July 21, 2021
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018