13 results · 18ms · Sources: EU EUDAMED, US FDA

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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