16 results · 19ms · Sources: EU EUDAMED, 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