13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SELENITE CYSTINE BROTH
FDA 510(k)
FDA Class 1
·Microbiology
Carnation Ambulatory Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL
FDA 510(k)
FDA Class 1
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 5, 2014
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 15, 2012
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 10, 2010
NEURO SPG-1X1"-STERILE- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 20, 2025
NEURO SPNG-1/2X3"-STRL- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 7, 2025
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